Endovascular device configured for selective narrowing

ABSTRACT

An endovascular device, including an elongated flexible sheath defining a lumen with an inner opening sized for enabling selective advancement of an endovascular instrument therethrough, the sheath having at least a first region and a second region; an electrode within the first region of the sheath; and a constrictor associated with the first region of the sheath, the constrictor being configured, while at least the first region and the second region of the sheath are positioned within a body and in response to an input received from outside the body, to reversibly narrow the lumen of the sheath in an area adjacent the electrode to thereby bring the electrode into contact with an adjacent portion of the endovascular instrument.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of International Application No.PCT/US2021/060223, filed Nov. 19, 2021, now pending, which claims thebenefit of priority of U.S. Provisional Patent Application No.63/116,105, filed Nov. 19, 2020; U.S. Provisional Patent Application No.63/221,254, filed Jul. 13, 2021; and U.S. Provisional Patent ApplicationNo. 63/260,522, filed Aug. 24, 2021, each of which is herebyincorporated by reference in its entirety.

TECHNICAL FIELD

The present disclosure relates to intravascular medical devices andsystems for treatment of vascular aneurysms, and methods of use thereof.In particular, the present disclosure relates to intravascular devicesand systems for sizing and delivery of embolic coil implants to vascularaneurysms.

BACKGROUND

An aneurysm is a ballooning or bulging of an artery at a weak spot inthe wall of an artery. Aneurysms frequently occur in the brain, aorta,intestines, spleen, and back of the knee. Endovascular treatment ofaneurysms, such as intra-cranial aneurysms, typically involves placing anumber of coils inside the aneurysm to stop the flow of blood to theaneurysm, thus removing the aneurysm from circulation and preventing theaneurysm sac from expanding or bleeding. The coils used for aneurysmtreatment are available in different sizes, with predetermined coillengths. Aneurysm treatment includes repeatedly advancing a coil througha catheter to the delivery site and detaching the coil from the catheterto fill the aneurysm; this method continues until the aneurysm iscompletely filled.

Proper filling of the aneurysm is crucial for treatment success, andsignificant packing of the coils is very important as remnant blood flowmay cause recurrence and aneurysm expansion, which may lead toadditional surgery or even patient death. On the other hand, if too manycoils are placed in the aneurysm, the coils may protrude from theaneurysm sac into the blood vessel and induce thrombus formation. Thismay occlude the vessel and cause a stroke, often leading to patientdisability or death.

Existing techniques for aneurysm treatment therefore present a dilemmafor physicians: if they either over-fill or under-fill the aneurysm, theprocedure success and the patient's health outcomes may be at risk. Inaddition, each coil detachment presents an inherent risk of detachmentmechanism failure or coil/microcatheter migration when detachmentoccurs, as well as wasted time and cost associated with each coil thatis not properly used. Thus, there remains a need for improved methodsfor delivering a desired length of coil to an aneurysm treatment site,so as to ensure that the aneurysm is filled with the proper amount ofcoil material. There also remains a need for aneurysm coil deliverytechniques that provide a reduced number of coil detachment steps, so asto mitigate the risks associated with coil detachment failure.

SUMMARY

Embodiments of the present disclosure may include a system for deliveryand cutting of an endovascular coil. The system may include a flexible,elongated microcatheter having a proximal end, a distal end, and atleast one inner lumen. The microcatheter may be configured foradvancement to a treatment area. The system may also include a helicalcoil configured to be advanced distally through the inner lumen of themicrocatheter and to extend through the distal end of the microcatheter.The system may also include a detachment mechanism situated at thedistal end of the microcatheter. The detachment mechanism may beconfigured to apply electrical current to the coil in order to cut asection of the coil arranged at the distal end of the microcatheter. Thesystem may also include a controller including a power source connectedto the detachment mechanism. When a desired length of the coil extendsthrough the distal end of the microcatheter, the detachment mechanismmay be configured to receive electrical current from the power sourceand apply the current to the coil. The application of current may cutthe section of the coil arranged at the distal end of the microcatheterand may release the desired length of the coil from the microcatheter.

According to another embodiment of the present disclosure, an apparatusfor cutting an endovascular coil may be provided. The apparatus mayinclude a cylindrical base having a proximal end, a distal end, and atleast one inner lumen. The cylindrical base may be configured to receivean endovascular coil within the at least one inner lumen. The apparatusmay additionally include an elongated spring beam extending from thedistal end of the cylindrical base. The apparatus may additionallyinclude a coil-cutting electrode on an inner surface of the spring beam.The coil-cutting electrode may be configured to apply electrical currentto the endovascular coil in order to sever a section of the endovascularcoil in contact with the coil-cutting electrode. The spring beam may beconfigured to move between an active position in which the spring beamis configured to press the coil-cutting electrode against a portion ofthe endovascular coil extending distally from the cylindrical base, anda rest position in which the spring beam reduces the contact forcebetween the coil-cutting electrode and the endovascular coil, relativeto the active position.

According to another embodiment of the present disclosure, anendovascular treatment system may be provided. The endovasculartreatment system may include a microcatheter configured to deliver anendovascular coil to an endovascular site and having at least one innerlumen. The microcatheter may include an apparatus for cutting anendovascular coil arranged within a distal end of the inner lumen of themicrocatheter. The apparatus may include a cylindrical base having aproximal end, a distal end, and at least one inner lumen. Thecylindrical base may be configured to receive an endovascular coilwithin the at least one inner lumen. The apparatus may additionallyinclude an elongated spring beam extending from the distal end of thecylindrical base. The apparatus may additionally include a coil-cuttingelectrode on an inner surface of the spring beam. The coil-cuttingelectrode may be configured to apply electrical current to theendovascular coil in order to sever a section of the endovascular coilin contact with the coil-cutting electrode. The spring beam may beconfigured to move between an active position in which the spring beamis configured to press the coil-cutting electrode against a portion ofthe endovascular coil extending distally from the cylindrical base, anda rest position in which the spring beam reduces the contact forcebetween the coil-cutting electrode and the endovascular coil, relativeto the active position. The endovascular treatment system mayadditionally include a power source configured to apply electric currentto the cylindrical base of the apparatus. When the power source appliesthe electric current to the cylindrical base, the spring beam of theapparatus may be configured to move into the active position to sever asection of the endovascular coil in contact with the coil-cuttingelectrode of the apparatus.

According to another embodiment of the present disclosure, a method ofmanufacturing an apparatus for cutting an endovascular coil may beprovided. The method of manufacturing may include providing acylindrical base having a proximal end, a distal end, and at least oneinner lumen. The method of manufacturing may additionally includeforming, at the distal end of the cylindrical base, an elongated springbeam extending from the distal end of the cylindrical base. The methodof manufacturing may additionally include forming a circumferential slitin a distal portion of the cylindrical base to produce at least firstand second torque poles connecting the spring beam to the cylindricalbase. The method of manufacturing may additionally include shape-settingthe first and second torque poles in a twisted configuration.

Consistent with disclosed embodiments, systems, devices, methods, andcomputer readable media for filling a hollow body structure aredisclosed. For example, an endovascular instrument for filling a hollowbody structure is disclosed. The embodiments may include an elongatedmember configured to exhibit differing coiling properties along a lengththereof. The elongated member may include a first region configured tobend in a first manner within the hollow body structure to form astabilizing frame. The elongated member may further include a secondregion proximal to the first region. The second region may be configuredto bend, after formation of the frame, in a second manner substantiallywithin the frame, thereby forming a curved mass substantially within theframe. The first region and the second region may be interconnected. Theembodiments may further include at least one structural property thatdiffers between the first region and the second region.

Consistent with disclosed embodiments, systems, devices, methods, andcomputer readable media for delivery of an endovascular instrument to atreatment site within a body are disclosed. The embodiments may includea flexible, elongated sheath having a proximal end and a distal end. Adistal section of the sheath may terminate at the distal end. Theembodiments may further include an inner wall of the sheath delimitingan inner lumen which may extend between the proximal end and the distalend of the sheath. The inner lumen may be sized to enable axialadvancement of the endovascular instrument therethrough. The embodimentsmay also include at least one electrode within the distal section of thesheath. The at least one electrode may be configured to selectivelydeliver an electric current through a segment of the endovascularinstrument within the inner lumen. The at least one electrode may beconfigured to selectively deliver the electric current through thesegment of the endovascular instrument while the distal section of thesheath may be positioned in the body.

Consistent with disclosed embodiments, systems, devices, methods, andcomputer readable media for causing a flow of electric current within aflexible elongated sheath in a body of a patient are disclosed.Embodiments may include obtaining an input for sending the electriccurrent from an electrode positioned within the flexible elongatedsheath through a segment of an endovascular instrument received withinan inner lumen of the sheath. Embodiments may further includecontrolling the flow of the electric current from the electrode throughthe segment of the endovascular instrument based on the input. The flowof the electric current may be in an amount sufficient to cause theendovascular instrument to be severed.

Consistent with disclosed embodiments, systems, devices, methods, andcomputer readable media containing instructions for endovasculartreatment are disclosed. The embodiments may include an elongatedflexible sheath defining a lumen with an inner opening sized forenabling selective advancement of an endovascular instrumenttherethrough. The sheath may have at least a first region and a secondregion. The embodiments may further include an electrode within thefirst region of the sheath. The embodiments may further include aconstrictor associated with the first region of the sheath, theconstrictor being configured, while at least the first region and thesecond region of the sheath are positioned within a body and in responseto an input received from outside the body, to reversibly narrow thelumen of the sheath in an area adjacent the electrode to thereby bringthe electrode into contact with an adjacent portion of the endovascularinstrument.

Consistent with additional disclosed embodiments, systems, devices,methods, and computer readable media containing instructions forendovascular treatment are disclosed. The embodiments may includedelivering an endovascular instrument to human vasculature via a sheathhaving an electrode therein. The embodiments may further include while aportion of the sheath having the electrode is within a body, reversiblyconstricting the portion of the sheath having the electrode to narrow alumen within the sheath and thereby cause the electrode and theendovascular instrument to make physical contact. The embodiments mayfurther include while the portion of the sheath having the electrode isconstricted, supplying electrical energy to the electrode, to therebydeliver electrical energy to the endovascular instrument via theelectrode.

Consistent with further disclosed embodiments, systems, devices,methods, and computer readable media containing instructions forendovascular treatment are disclosed. The embodiments may includeobtaining an input corresponding to delivery of an endovascularinstrument to human vasculature via a sheath having an electrodetherein. The embodiments may further include based on the input, andwhile a portion of the sheath having the electrode is within a body,causing reversible constriction of the portion of the sheath having theelectrode to narrow a lumen within the sheath and thereby cause theelectrode and the endovascular instrument to make physical contact. Theembodiments may further include while the portion of the sheath havingthe electrode is constricted, controlling supply of electrical energy tothe electrode, to thereby deliver electrical energy to the endovascularinstrument via the electrode.

Consistent with disclosed embodiments, systems, devices, methods, andcomputer readable media containing instructions for controlling aballoon affixed to a catheter in a body of a patient are disclosed. Theembodiments may include an elongated catheter having an inner lumenextending therethrough. The embodiments may further include a balloonaffixed to the catheter for expansion into the inner lumen of thecatheter when the balloon is inflated. The embodiments may furtherinclude a tube secured relative to the balloon. The tube may beconfigured to enable selective inflation and deflation of the balloon.An outer diameter of a portion of the catheter adjacent the balloon maybe substantially the same when the balloon is inflated and when theballoon is deflated.

Consistent with additional disclosed embodiments, systems, devices,methods, and computer readable media containing instructions forcontrolling a balloon affixed to a catheter in a body of a patient aredisclosed. The embodiments may include obtaining a first input forinflating the balloon. The embodiments may further include, in responseto the first input, initiating fluid flow through a conduit connected tothe balloon to cause inflation of the balloon. The inflation may causethe balloon to expand into an inner lumen of the catheter. Theembodiments may further include, after causing the inflation of theballoon, obtaining a second input for deflating the balloon. Theembodiments may further include, in response to the second input,causing deflation of the balloon with the conduit. An outer diameter ofa portion of the catheter adjacent the balloon may be substantially thesame when the balloon is inflated and when the balloon is deflated.

Consistent with disclosed embodiments, systems, devices, methods, andcomputer readable media containing instructions for monitoringpartitioning of a medical instrument during an endovascular procedureare disclosed. The embodiments may include obtaining an input toactivate a partitioning mechanism associated with a medical instrumentwithin a lumen of a catheter, the catheter being positioned within abody. The embodiments may further include in response to the input,activating the partitioning mechanism. The embodiments, following theactivation, may also be configured to obtain partitioning outcome data.Embodiments may also determine, based on the partitioning outcome data,whether the medical instrument may be in a served state or a connectedstate. Some embodiments may, if the severed state of the medicalinstrument is detected, output a success notification. Further, if theconnected state of the medical instrument is detected, embodiments mayoutput at least one of (i) a control signal to vary activation of thepartitioning mechanism or (ii) an instruction to reposition the medicalinstrument relative to the partitioning mechanism.

Consistent with additional disclosed embodiments, systems, devices,methods, and computer readable media containing instructions formonitoring partitioning of a medical instrument during an endovascularprocedure are disclosed. The embodiments may include at least oneprocessor configured to obtain an input to activate a partitioningmechanism associated with a medical instrument within a lumen of acatheter, the catheter being positioned within a body. The embodimentsmay further include in response to the input, activating thepartitioning mechanism. The embodiments, following the activation, mayalso be configured to obtain partitioning outcome data. Embodiments mayalso determine, based on the partitioning outcome data, whether themedical instrument may be in a severed state or a connected state. Insome embodiments, if the severed state of the medical instrument isdetected, a success notification may be output. Further, if theconnected state of the medical instrument is detected, embodiments mayoutput at least one of (i) a control signal to vary activation of thepartitioning mechanism or (ii) an instruction to reposition the medicalinstrument relative to the partitioning mechanism.

Consistent with further disclosed embodiments, systems, devices,methods, and computer readable media containing instructions formonitoring partitioning of a medical instrument during an endovascularprocedure are disclosed. The embodiments may include obtaining an inputto activate a partitioning mechanism associated with a medicalinstrument within a lumen of a catheter, the catheter being positionedwithin a body. The embodiments may further include in response to theinput, activating the partitioning mechanism. The embodiments, followingthe activation, may also be configured to obtain partitioning outcomedata. Embodiments may also determine, based on the partitioning outcomedata, whether the medical instrument may be in a served state or aconnected state. Some embodiments may, if the severed state of themedical instrument is detected, output a success notification. Further,if the connected state of the medical instrument is detected,embodiments may output at least one of (i) a control signal to varyactivation of the partitioning mechanism or (ii) an instruction toreposition the medical instrument relative to the partitioningmechanism.

Consistent with disclosed embodiments, systems, devices, methods, andnon-transitory computer readable media containing instructions forfacilitating endovascular coil delivery are disclosed. The embodimentsmay include obtaining a first input from a coil movement sensorassociated with an endovascular coil within a lumen of a catheterpositioned within a body. The catheter may include a coil partitioningmechanism configured to sever the endovascular coil. The embodiments mayfurther include obtaining, after the first input, a second input toactivate the coil partitioning mechanism. The embodiments may furtherinclude activating, in response to the second input, the coilpartitioning mechanism to sever the endovascular coil into a first coilsection for delivery from the catheter and a residual second coilsection. The embodiments may further include determining, based on atleast the first input and the second input, a length of the second coilsection. The embodiments may further include outputting a signal basedon the determined length of the second coil section.

Consistent with additional disclosed embodiments, systems, devices,methods, and non-transitory computer readable media containinginstructions for monitoring endovascular coil delivery are disclosed.The embodiments may include at least one processor configured to obtaina first input from a coil movement sensor associated with anendovascular coil within a lumen of a catheter positioned within a body.The catheter may include a coil partitioning mechanism configured tosever the endovascular coil. The at least one processor may be furtherconfigured to obtain, after the first input, a second input to activatethe coil partitioning mechanism. The at least one processor may befurther configured to activate, in response to the second input, thecoil partitioning mechanism to sever the endovascular coil into a firstcoil section for delivery from the catheter and a residual second coilsection. The at least one processor may be further configured todetermine, based on at least the first input and the second input, alength of the second coil section. The at least one processor may befurther configured to output a signal based on the determined length ofthe second coil section.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this disclosure, illustrate various disclosed embodiments. Inthe drawings:

FIG. 1 illustrates a system for severing an endovascular coil,consistent with disclosed embodiments.

FIGS. 2A and 2B illustrate a system for severing an endovascular coil,consistent with disclosed embodiments.

FIG. 3 illustrates a system for severing an endovascular coil,consistent with disclosed embodiments.

FIG. 4 illustrates a system for severing an endovascular coil,consistent with disclosed embodiments.

FIG. 5A illustrates a system for severing an endovascular coil,consistent with disclosed embodiments.

FIG. 5B illustrates the system of FIG. 5A without the microcatheter,consistent with disclosed embodiments.

FIG. 6 depicts a flowchart illustrating a method of delivering andsevering an endovascular coil, consistent with disclosed embodiments.

FIG. 7A illustrates an apparatus for severing an endovascular coilhaving a spring beam in a rest position, consistent with disclosedembodiments.

FIG. 7B depicts a front, top perspective view of the apparatus of FIG.7A, consistent with disclosed embodiments.

FIG. 8A illustrates the apparatus of FIG. 7A with the spring beam in anactive position, consistent with disclosed embodiments.

FIG. 8B illustrates an enlarged view of the apparatus of FIG. 8A,consistent with disclosed embodiments.

FIGS. 9A-9D illustrate a method of delivering and severing anendovascular coil, consistent with disclosed embodiments.

FIG. 10A illustrates another example of an apparatus for severing anendovascular coil, consistent with disclosed embodiments.

FIG. 10B illustrates the apparatus of FIG. 10A with the spring beam in arest position, consistent with disclosed embodiments.

FIG. 10C illustrates the apparatus of FIG. 10A with the spring beam inan active position, consistent with disclosed embodiments.

FIG. 11 depicts a flowchart illustrating a method of manufacturing anapparatus for severing an endovascular coil, consistent with disclosedembodiments.

FIG. 12A is a side view and FIG. 12B is an interior view of an exampleof an endovascular device configured for delivery of an endovascularinstrument, consistent with disclosed embodiments.

FIG. 13 is a perspective side view of an example of an outer tube of theendovascular device of FIGS. 12A and 12B, consistent with disclosedembodiments.

FIG. 14 is a perspective side view of an example of an elongated sheathof the endovascular device of FIGS. 12A and 12B, consistent withdisclosed embodiments.

FIG. 15A is a perspective view of the elongated sheath of FIG. 14 with aballoon in a first configuration, consistent with disclosed embodiments.

FIG. 15B is a perspective view of the elongated sheath of FIG. 14 withthe balloon in a second configuration, consistent with disclosedembodiments.

FIG. 16A is an interior view of a distal section of the endovasculardevice of FIGS. 12A and 12B in an unconstricted state, consistent withdisclosed embodiments.

FIGS. 16B and 16C depict cross-sectional views of the endovasculardevice of FIG. 16A in the unconstricted state, consistent with disclosedembodiments.

FIG. 17A is an interior view of the distal section of the endovasculardevice of FIGS. 12A and 12B in a constricted state, consistent withdisclosed embodiments.

FIGS. 17B and 17C depict cross-sectional views of the endovasculardevice of FIG. 17A in the constricted state, consistent with disclosedembodiments.

FIGS. 18A and 18B depict an example of an endovascular instrument beingsevered by the endovascular device of FIGS. 12A and 12B, consistent withdisclosed embodiments.

FIG. 19 is a block diagram of an example of a system for monitoring andcontrolling endovascular devices and procedures, consistent withdisclosed embodiments.

FIG. 20A depicts an example of an endovascular instrument includingmultiple regions with different structural properties, consistent withdisclosed embodiments.

FIG. 20B depicts the regions of the endovascular instrument of FIG. 20Ain respective bent states, consistent with disclosed embodiments.

FIG. 21A depicts another example of an endovascular instrument includingmultiple regions with different structural properties, consistent withdisclosed embodiments.

FIG. 21B depicts the regions of the endovascular instrument of FIG. 21Ain respective bent states, consistent with disclosed embodiments.

FIGS. 22A-22F depict an example of a method for delivering anendovascular instrument into a hollow body structure with theendovascular device of FIGS. 12A and 12B, consistent with disclosedembodiments.

FIG. 23 is an interior view of the endovascular device of FIGS. 12A and12B in a configuration for obstructing axial advancement of anendovascular instrument, consistent with disclosed embodiments.

FIG. 24 is an interior view of the endovascular device of FIGS. 12A and12B exerting a frictional force on an endovascular instrument,consistent with disclosed embodiments.

FIG. 25A is an interior view of an example of an endovascular device andan endovascular instrument including a support mechanism, consistentwith disclosed embodiments.

FIG. 25B is another interior view of the endovascular device of FIG.25A, with the endovascular instrument pushed distally by the supportmechanism, consistent with disclosed embodiments.

FIGS. 26A and 26B depict interior views of an example of an endovasculardevice including a coil movement sensor, consistent with disclosedembodiments.

FIG. 27 illustrates a method of monitoring and facilitating endovascularcoil delivery, consistent with disclosed embodiments.

FIG. 28 is a flowchart of an exemplary endovascular treatment method,consistent with disclosed embodiments.

FIG. 28 is a flowchart of an example of an endovascular treatmentmethod, consistent with disclosed embodiments.

FIG. 29 is a flowchart of an example of a method for controlling aballoon affixed to a catheter in a body of a patient, consistent withdisclosed embodiments.

FIG. 30 is a flowchart of an example of a method for controlling atleast one of inflation or deflation of a balloon based on data derivedfrom a medical image, consistent with disclosed embodiments.

FIG. 31 is a flowchart of an operation for monitoring partitioning of amedical instrument during an endovascular procedure, consistent withdisclosed embodiments.

FIG. 32 is a flowchart of an operation for activating the partitioningmechanism in response to an input, consistent with disclosedembodiments.

FIG. 33 is a flowchart of an operation for determining whether themedical instrument is in a partitioning readiness state, consistent withdisclosed embodiments.

FIG. 34 is a flowchart of an operation for obtaining partitioningoutcome data following the activation, consistent with disclosedembodiments.

FIG. 35 is another flowchart of an operation for obtaining partitioningoutcome data following the activation, consistent with disclosedembodiments.

FIG. 36 is a flowchart of an operation for determining, based on thepartitioning outcome data, whether the medical device is in a severedstate or a connected state, consistent with disclosed embodiments.

FIG. 37 depicts at least one controller with an input configured tocontrol flow of electric current, consistent with disclosed embodiments.

DETAILED DESCRIPTION

Exemplary embodiments are described with reference to the accompanyingdrawings. In the figures, which are not necessarily drawn to scale, theleft-most digit(s) of a reference number identifies the figure in whichthe reference number first appears. Wherever convenient, the samereference numbers are used throughout the drawings to refer to the sameor like parts. While examples and features of disclosed principles aredescribed herein, modifications, adaptations, and other implementationsare possible without departing from the spirit and scope of thedisclosed embodiments. Also, the words “comprising,” “having,”“containing,” and “including,” and other similar forms are intended tobe equivalent in meaning and be open ended in that an item or itemsfollowing any one of these words is not meant to be an exhaustivelisting of such item or items, or meant to be limited to only the listeditem or items. It should also be noted that as used in the presentdisclosure and in the appended claims, the singular forms “a,” “an,” and“the” include plural references unless the context clearly dictatesotherwise.

Unless specifically stated otherwise, as apparent from the followingdescription, throughout the specification discussions utilizing termssuch as “processing,” “calculating,” “computing,” “determining,”“generating,” “setting,” “configuring,” “selecting,” “defining,”“applying,” “obtaining,” “monitoring,” “providing,” “identifying,”“segmenting,” “classifying,” “analyzing,” “associating,” “extracting,”“storing,” “receiving,” “transmitting,” or the like, include actionsand/or processes of a computer that manipulate and/or transform datainto other data, the data represented as physical quantities, forexample such as electronic quantities, and/or the data representingphysical objects. The terms “computer,” “processor,” “controller,”“processing unit,” “control unit,” “computing unit,” and “processingmodule” should be expansively construed to cover any kind of electronicdevice, component or unit with data processing capabilities, including,by way of non-limiting example, a personal computer, a wearablecomputer, smart glasses, a tablet, a smartphone, a server, a computingsystem, a cloud computing platform, a communication device, a processor(for example, digital signal processor (DSP), an image signal processor(ISR), a microcontroller, a field programmable gate array (FPGA), anapplication specific integrated circuit (ASIC), a central processingunit (CPA), a graphics processing unit (GPU), a visual processing unit(VPU), and so on), possibly with embedded memory, a single coreprocessor, a multi core processor, a core within a processor, any otherelectronic computing device, or any combination of the above. Theoperations in accordance with the teachings herein may be performed by acomputer specially constructed or programmed to perform the describedfunctions.

As used herein, the phrase “for example,” “such as,” “for instance” andvariants thereof describe non-limiting embodiments of the presentlydisclosed subject matter. Reference in the specification to features of“embodiments,” “one case,” “some cases,” “other cases” or variantsthereof means that a particular feature, structure or characteristicdescribed may be included in at least one embodiment of the presentlydisclosed subject matter. Thus the appearance of such terms does notnecessarily refer to the same embodiment(s). As used herein, the term“and/or” includes any and all combinations of one or more of theassociated listed items.

Features of the presently disclosed subject matter, are, for brevity,described in the context of particular embodiments. However, it is to beunderstood that features described in connection with one embodiment arealso applicable to other embodiments. Likewise, features described inthe context of a specific combination may be considered separateembodiments, either alone or in a context other than the specificcombination.

In embodiments of the presently disclosed subject matter, one or morestages or steps illustrated in the figures may be executed in adifferent order and/or one or more groups of stages may be executedsimultaneously and vice versa. The figures illustrate a generalschematic of the system architecture in accordance embodiments of thepresently disclosed subject matter. Each module in the figures can bemade up of any combination of software, hardware and/or firmware thatperforms the functions as defined and explained herein. The modules inthe figures may be centralized in one location or dispersed over morethan one location.

Examples of the presently disclosed subject matter are not limited inapplication to the details of construction and the arrangement of thecomponents set forth in the following description or illustrated in thedrawings. The subject matter may be practiced or carried out in variousways. Also, it is to be understood that the phraseology and terminologyemployed herein is for the purpose of description and should not beregarded as limiting.

In this document, an element of a drawing that is not described withinthe scope of the drawing and is labeled with a numeral that has beendescribed in a previous drawing may have the same use and description asin the previous drawings. The drawings in this document may not be toany scale. Different figures may use different scales and differentscales can be used even within the same drawing, for example differentscales for different views of the same object or different scales forthe two adjacent objects.

Consistent with disclosed embodiments, “at least one processor” mayconstitute any physical device or group of devices having electriccircuitry that performs a logic operation on an input or inputs. Forexample, the at least one processor may include one or more integratedcircuits (IC), including application-specific integrated circuit (ASIC),microchips, microcontrollers, microprocessors, all or part of a centralprocessing unit (CPU), graphics processing unit (GPU), digital signalprocessor (DSP), field-programmable gate array (FPGA), server, virtualserver, or other circuits suitable for executing instructions orperforming logic operations. The instructions executed by at least oneprocessor may, for example, be pre-loaded into a memory integrated withor embedded into the controller or may be stored in a separate memory.The memory may include a Random Access Memory (RAM), a Read-Only Memory(ROM), a hard disk, an optical disk, a magnetic medium, a flash memory,other permanent, fixed, or volatile memory, or any other mechanismcapable of storing instructions. In some embodiments, the at least oneprocessor may include more than one processor. Each processor may have asimilar construction or the processors may be of differing constructionsthat are electrically connected or disconnected from each other. Forexample, the processors may be separate circuits or integrated in asingle circuit. When more than one processor is used, the processors maybe configured to operate independently or collaboratively. Theprocessors may be coupled electrically, magnetically, optically,acoustically, mechanically or by other means that permit them tointeract.

Disclosed embodiments may include and/or access a data structure. A datastructure consistent with the present disclosure may include anycollection of data values and relationships among them. The data may bestored linearly, horizontally, hierarchically, relationally,non-relationally, uni-dimensionally, multidimensionally, operationally,in an ordered manner, in an unordered manner, in an object-orientedmanner, in a centralized manner, in a decentralized manner, in adistributed manner, in a custom manner, or in any manner enabling dataaccess. By way of non-limiting examples, data structures may include anarray, an associative array, a linked list, a binary tree, a balancedtree, a heap, a stack, a queue, a set, a hash table, a record, a taggedunion, ER model, and a graph. For example, a data structure may includean XML database, an RDBMS database, an SQL database or NoSQLalternatives for data storage/search such as, for example, MongoDB,Redis, Couchbase, Datastax Enterprise Graph, Elastic Search, Splunk,Solr, Cassandra, Amazon DynamoDB, Scylla, HBase, and Neo4J. A datastructure may be a component of the disclosed system or a remotecomputing component (e.g., a cloud-based data structure). Data in thedata structure may be stored in contiguous or non-contiguous memory.Moreover, a data structure, as used herein, does not require informationto be co-located. It may be distributed across multiple servers, forexample, that may be owned or operated by the same or differententities. Thus, the term “data structure” as used herein in the singularis inclusive of plural data structures.

Embodiments of the present disclosure relate generally to devices,systems, and methods for the continuous filling of a coil from amicrocatheter into an aneurysm until the aneurysm is completely filled.The exemplary devices and systems may be configured to cut the coil atthe distal end of the microcatheter, thus detaching the coil from themicrocatheter. Advantageously, devices, systems, and methods describedherein may provide optimal filling of the aneurysm sac with the coil,thus allowing a superior degree of aneurysm occlusion. In addition, thedelivery and cutting of a single coil eliminates the need for multiplecoil detachment steps; this may reduce the risk for detachment mechanismfailure, mitigate microcatheter displacement, and provide shorterprocedure time. Further, exemplary devices, systems, and methodsdescribed herein may eliminate stiff, rigid detachment junctions presentin prior aneurysm treatment devices.

FIG. 1 illustrates an exemplary system 100 for endovascular coil cuttingwith a coil-cutting apparatus 140. System 100 may include amicrocatheter 110, a helical coil 120, and a controller (not shown)including a power source such as an electrical generator. Microcatheter110 may be navigated to a treatment area within the patient's body usinga guidewire, after which the guidewire may be removed. In someembodiments, coil 120 may be constructed of Nitinol, platinum, nickel,iridium, tungsten, an alloy (e.g., a platinum/tungsten alloy) and/or anyother suitable material. Coil 120 may be introduced through an innerlumen 114 of microcatheter 110 and into the treatment area. Once adesired length of coil 120 extends from the distal end 112 of themicrocatheter (e.g., with the desired coil length situated within thetreatment area (not shown)), the coil-cutting apparatus 140 at thedistal end 112 of the microcatheter may be connected to the power sourceand electrical current delivered to the coil 120 via the coil-cuttingapparatus 140 to locally melt and cut the coil. The remaining length ofcoil 120 may then be removed from microcatheter 110.

In some embodiments, the coil-cutting apparatus 140 may include twoelectrodes 142, 144 situated at the distal end 112 of the microcatheter.Electrodes 142, 144 may be connected via wires 143, 145 (e.g., copperwires) to the proximal end of microcatheter 110 and to the controllerand power source. At the distal end 112 of the microcatheter, theelectrodes 142, 144 may maintain active or passive contact with coil120. For example, when a coil detachment action is initiated via thecontroller, the power source may generate a high current pulse which isdelivered to electrodes 142, 144 by wires 143, 145. In some embodiments,the controller may send a signal, wireless or otherwise, to the powersource to generate the high current pulse. Electrodes 142, 144 may applythe high current pulse to the coil section 124 arranged between theelectrodes; the high resistance of the coil section 124, relative to thecoil-cutting apparatus 140, causes the coil section to locally melt andsevers the coil 120 at coil section 124. As a result, the distal segment122 of the coil may be detached from microcatheter 110 and from theremainder of the coil, so that distal segment 122 may remain in ananeurysm or other treatment area.

FIG. 1 illustrates an example of a passive coil-cutting apparatus 140.At the distal end 112 of the microcatheter, electrodes 142, 144 may beembedded within the wall of the microcatheter and may extend into theinner lumen 114 of the microcatheter to create contact betweenelectrodes 142, 144 and coil 120. In the example shown in FIG. 1,electrodes 142, 144 may bulge into the microcatheter lumen from oppositesides, with a short axial distance 146 provided between them (e.g., adistance of between 1-2 mm). This arrangement may force coil section 124to pass in an “S” path between electrodes 142, 144, which increaseselectrical contact between coil 120 and electrodes 142, 144.

FIGS. 2A and 2B illustrate another exemplary system 200 for endovascularcoil cutting. System 200 may include an active coil-cutting apparatus240 (that is, a coil-cutting apparatus that may be activated by a user).In the example shown in FIGS. 2A and 2B, electrodes 242, 244 may includea conductive ring 247, 248, respectively. Rings 247, 248 may beconstructed of the same material as wires 243, 245 (e.g., copper) or,alternatively, rings 247, 248 may be constructed of any suitableconductive material such as copper or beryllium copper, which may begold-coated. In an inactivated state depicted in FIG. 2A, rings 247, 248may be held out of contact with coil 120. The coil-cutting apparatus 240may be activated via the controller and current may be delivered toelectrodes 242, 244 via wires 243, 245, respectively. Rings 247, 248 maybe actuated (e.g., mechanically, electrically, hydraulically or othermeans of actuation) to move into contact with coil 120; this is shown inthe activated state of FIG. 2B. When the rings 247, 248 are inelectrical contact with coil 120 in the activated state, the rings maydeliver electrical current to the coil and locally cut the coil, thusdetaching the distal coil segment 122.

FIG. 3 illustrates another exemplary system 300 for endovascular coilcutting having a passive coil-cutting apparatus 340. At themicrocatheter distal end 112, coil-cutting apparatus 340 may includeelectrodes 342, 344 that may bulge into the microcatheter lumen 114 fromopposite sides to form passive elements 347, 348 configured, forexample, as leaf springs. Passive elements 347, 348 may be biased towardthe center of microcatheter 110, such that electrodes 342, 344 mayremain in contact with coil 120 even while the coil is moved distally orproximally. When an electrical current pulse is received from the powersource and delivered to electrodes 342, 344 via wires 343, 345,respectively, passive elements 347, 348 may pass the current throughcoil section 124 to sever the coil. As a result, the distal segment 122of the coil may be detached from microcatheter 110 and from theremainder of the coil 120.

FIG. 4 illustrates another exemplary system 400 for endovascular coilcutting having a passive coil-cutting apparatus 440. Coil-cuttingapparatus 440 may include electrodes 442, 444, which may be spaced apartaxially along microcatheter 110. Electric current may be delivered toelectrodes 442, 444 via wires 443, 445, respectively. In someembodiments, electrodes 442, 444 may include passive elements 447, 448configured, for example, as leaf springs or elastic fingers. Passiveelements 447, 448 may be biased into the microcatheter lumen 114 so thatelectrodes 442, 444 maintain electrical contact with coil 120. In theexample of FIG. 4, electrode 442 may include a plurality of passiveelements 447 spaced apart circumferentially, each of which may be biasedinwards to contact coil 120. Similarly, electrode 444 may include aplurality of passive elements 448 spaced apart circumferentially, eachof which may be biased inwards to contact coil 120. Advantageously, thepresence of multiple passive elements on each electrode maximizes thelikelihood that electrical contact is maintained between electrodes 442,444 and coil 120, even when the coil is moved relative to microcatheter110.

FIG. 5A illustrates another exemplary system 500 for endovascular coilcutting having a passive coil-cutting apparatus 540. For purposes ofillustration, FIG. 5B depicts system 500 and coil-cutting apparatus 540without microcatheter 110, with a cross-sectional view of electrodes542, 544 and a perspective view of wires 543, 545. Coil-cuttingapparatus 540 may include electrodes 542, 544 having passive elements547, 548, respectively, which may be biased inwards from opposite sidesof the microcatheter. Due to the spring-like configuration of passiveelements 547, 548, electrical contact may be maintained between theelectrodes and coil 120.

FIG. 6 illustrates an exemplary method 600 of delivering and cutting anendovascular coil. The exemplary steps of method 600 are describedherein with reference to system 100; however, one of ordinary skill willunderstand that method 600 may additionally or alternatively beperformed using any other system or device disclosed herein (including,and not limited to, systems 200, 300, 400, and 500).

In step 602, coil 120 may be advanced distally relative to microcatheter110 until a desired length of distal coil segment 122 extends from thedistal end 112 of the microcatheter. When distal coil segment 122 hasthe desired length, coil segment 124 (referred to hereafter as thecutting point) may be situated at the coil-cutting apparatus; in theexample of FIG. 1, coil segment 124 is situated between the bulges ofelectrodes 142, 144.

In step 604, the electrodes of the coil-cutting apparatus may be broughtinto contact with coil 120. Step 604 may not be necessary forembodiments having a passive coil-cutting apparatus (in which theelectrodes maintain contact with the coil even in the absence of useractivation). However, for embodiments having an active coil-cuttingapparatus, the user may take the requisite activation step (e.g.,pressing a button on the controller) to bring the electrodes intoelectrical contact with coil 120.

In step 606, the controller may measure the electrical resistance at thecoil-cutting apparatus to confirm proper contact between the electrodesand coil. Contact may be confirmed when the electrical resistance isdetermined to be below a threshold (e.g., below 10Ω). In someimplementations, the medium between the electrodes may have a relativelyhigh electrical resistance. Thus, when proper contact is establishedbetween the electrodes and the coil, the resistance will decreasesignificantly due to the much lower electrical resistance of the coilmaterial. The decreased resistance results in a sufficiently highelectrical current for cutting the coil.

When contact is confirmed, the controller may cause the power source togenerate an electrical pulse at step 608 to cut the coil. In someimplementations, the electrical pulse may have current between 1.0 and4.0 A at a voltage of 36 v. The electrical pulse may have a shortcurrent pulse duration (e.g., between one and two seconds) to mitigatethe heating risk to the patient and to avoid damaging the microcatheter.

In step 610, the controller may re-measure the electrical resistance atthe coil-cutting apparatus to determine whether the coil was completelysevered. For example, the controller may determine if the resistance hasincreased, indicating that the coil has been completely severed. If thecut is confirmed (“yes” at step 610), the cutting process is completed.If the cut is not confirmed (“no” at step 610), method 600 may return tostep 606 and repeat the steps until the cutting of the coil is confirmedat step 610.

Example 1

A calculation of the electrical parameters for an exemplary systemdisclosed herein is provided below. This calculation demonstratesconcept feasibility.

$\begin{matrix}{R = {\rho\frac{l}{A}}} & ( {{Equation}\mspace{14mu} 1} )\end{matrix}$

In which “R” corresponds to electrical resistance [Ω], “p” correspondsto electrical resistivity [Ω*m], “l” corresponds to length [m], and “A”corresponds to cross-sectional area [mm²].

$\begin{matrix}{I = \frac{V}{R}} & ( {{Equation}\mspace{14mu} 2} )\end{matrix}$

In which “I” corresponds to current [A], “R” corresponds to electricalresistance [Ω], and “V” corresponds to voltage [V].

In one implementation, the coil-cutting apparatus may require:

-   -   maximum overall allowed resistance: R≤10[Ω];    -   maximum allowed voltage: V≤36 [V]; and    -   minimum cutting current: 1 [A]≤I≤4 [A].

Here, overall resistance may include the resistance of the electrodewires and the resistance of the coil contact points.

An example of parameters for an exemplary system for cutting animplantable coil, such as an aneurysm coil, may include:

-   -   Microcatheter length: l=1.5 [m];    -   Electrode wire resistivity: copper resistivity ρ=1.71*10⁻⁸ [Ω*m]        (20° C.);    -   Electrode wire diameter: d=70 μm; and    -   Electrode wire cross-sectional area: A=π*(35*10⁻⁶)²=3.848*10⁻⁹        [m²].

These parameters of the exemplary system may be used in Equations 1 and2 as follows:

$R = {{\rho\frac{l}{A}} = {{{1.7}1*10^{- 8}*\frac{3}{{3.8}48*10^{- 9}}} = {1{3.{2\lbrack\Omega\rbrack}}}}}$$I = {\frac{V}{R} = {\frac{36}{1{3.2}} = {{{2.7}{2\lbrack A\rbrack}} \geq {{minimum}\mspace{20mu}{requirement}}}}}$

The determined current value of 2.72 A is greater than the minimumcurrent 1.0 A required to sever an endovascular coil having thedimensions discussed above. Thus, the disclosed system is an effectivemeans for controlled cutting of the coil.

FIGS. 7A-8B illustrate an exemplary system 700 for delivering andcutting an endovascular coil 120, such as a coil for treatment of ananeurysm. System 700 may include a microcatheter 710 and a coil-cuttingapparatus 740 situated partially or entirely within the distal portionof microcatheter 710. (Solely for illustrative purposes, microcatheter710 is depicted in a cross-sectional view in FIGS. 7A and 8A.) FIGS. 7Aand 7B depict coil-cutting apparatus 740 having a spring beam 760 in anexemplary rest position and FIGS. 8A and 8B depict coil-cuttingapparatus 740 having a spring beam 760 in an exemplary active position,as discussed in detail below.

Microcatheter 710 may have a similar configuration as microcatheter 110described above and may be configured for delivery of a therapeuticdevice, such as coil 120, to a treatment site. Coil-cutting apparatus740 may be situated within and connected to the inner lumen ofmicrocatheter 710, at or near the distal end of microcatheter 710. Insome embodiments, coil-cutting apparatus 740 may be arranged relative tomicrocatheter 110 such that the distal-most portion of coil-cuttingapparatus 740 (i.e., spring beam distal end 761, as discussed below) iseven or substantially even with the distal-most end of microcatheter710. In some alternative embodiments, spring beam distal end 761 may belocated in a proximal direction from the distal-most end ofmicrocatheter 710, so as to provide clearance between coil-cuttingapparatus 740 and the distal end of the microcatheter.

Coil-cutting apparatus 740 may include a cylindrical base 750 having atleast one inner lumen 756. Cylindrical base 750 may have an annular orelliptical cross-sectional shape and may be configured to receive coil120 within the inner lumen 756. In some embodiments, cylindrical base750 may have an inner diameter (i.e., the diameter of inner lumen 756)of between approximately 0.38 mm and 0.40 mm. For example, cylindricalbase 750 may have an inner diameter of 0.38 mm, 0.39 mm, or 0.40 mm.Additionally, or alternatively, cylindrical base 750 may have an outerdiameter of between approximately 0.45 mm and 0.50 mm. For example,cylindrical base 750 may have an outer diameter of 0.45 mm, 0.46 mm,0.47 mm, 0.48 mm, 0.49 mm, or 0.50 mm. In some embodiments, the outersurface of cylindrical base 750 may be directly connected to the innerwall of microcatheter 710 by adhesive, welding, soldering, or othersuitable techniques.

In some embodiments, a slit 752 may be formed near the distal end ofcylindrical base 750. Slit 752 may extend through the side wall ofcylindrical base 750, passing between inner and outer surfaces ofcylindrical base 750. For example, slit 752 may be formed in cylindricalbase 750, such as by laser cutting or photochemical etching. In someembodiments, slit 752 may have a length within the range of 0.05 mm to0.2 mm in the Z-direction of FIG. 7A. For example, slit 752 may have arelatively short length in the Z-direction so that torque poles 754 a,754 b may be formed (as discussed in detail below) without comprisingthe structural integrity of cylindrical base 750. Additionally, oralternatively, slit 752 may be situated a distance within the range of0.05 mm to 0.3 mm from the distal end of cylindrical base 750, relativeto the Z-direction. Slit 752 may extend along a portion of thecircumference of cylindrical base 750, such that the slit 752 does notextend into section 751 of the cylindrical base 750. For example, slit752 may have an arc length within the range of 110° to 130° about thecircumference of cylindrical base 750.

As shown in FIG. 7B, cylindrical base 750 may include torque poles 754a, 754 b extending longitudinally between slit 752 and the distal end ofthe cylindrical base. Torque poles 754 a and 754 b may form acontinuous, arc-shaped structure adjacent to slit 752 that is connectedto the remainder of the cylindrical base 750 at connection points 755 aand 755 b. That is, torque poles 754 a, 754 b may extend in acircumferential direction along the distal end of cylindrical base 750,adjacent to slit 752.

Coil-cutting apparatus 740 may also include an elongated spring beam 760extending in a distal direction from the distal end of cylindrical base750. Thus, the distal end 761 of spring beam 760 may be situateddistally from the distal end of cylindrical base 750. Proximal end 762of spring beam 760 may be connected to torque poles 754 a, 754 b, whichmay form the connection between spring beam 760 and cylindrical base750. In some embodiments, outer surface 763 of the spring beam may beeven with the outer surface of cylindrical base 750 (i.e., the outersurface of torque poles 754 a, 754 b). Additionally, or alternatively,outer surface 763 may be rounded with a curvature that is equal to (orsubstantially similar to) the curvature of the outer surface ofcylindrical body 750. Advantageously, this configuration may prevent theformation of sharp edges on the intersection between cylindrical base750 and spring beam 760 that may be harmful to the patient. In someembodiments, spring beam 760 may have a length within the range of 1.0mm to 2.0 mm in the Z-direction and a width within the range of 0.1 mmto 0.3 mm in the X-direction. For example, the width of spring beam 760in the X-direction may be smaller than the inner diameter of cylindricalbase 750.

As shown in FIG. 7A, the inner, coil-facing surface 764 of the springbeam 760 may include at least one coil-cutting electrode 742. Whencoil-facing surface 764 is pressed against coil 120, electrode 742 mayapply electrical current to the coil in order to sever the section ofthe coil in contact with the electrode. As a result, the coil segmentdistal to electrode 742 may be detached from the remainder of the coil120. In some embodiments, coil-cutting electrode 742 may simply be theportion of coil-facing surface 764 that contacts coil 120; the portionof coil-facing surface 764 at the location of electrode 742 may beconfigured as an electrode due to the high conductivity of spring beam760 and cylindrical base 750. Additionally, or alternatively, one ormore electrodes constructed of any suitable conductive material may beattached to spring beam 760 at the location 742. Advantageously, theplacement of electrode 742 within microcatheter 710 prevents contactbetween the electrode and the patient's body.

Cylindrical base 750 (including torque poles 754 a and 754 b) and springbeam 760 may be constructed from a shape-memory alloy such as Nitinol.In some embodiments, spring beam 760 may be curved or arc-shaped so asto form a convex shape relative to inner lumen 756 of the cylindricalbase (i.e., the proximal and distal ends of the spring beam may pointaway from inner lumen 756). For example, spring beam 760 may beshape-set in the curved or arc-shaped configuration. Electrode 742 maybe situated in the middle of spring beam 760, at the apex of the curveor arc. Advantageously, the spring beam distal end 761 may be situatedabove (relative to the vertical Y-direction) the apex of the curvedspring beam 760 in the configuration shown in FIGS. 7A and 7B,minimizing the likelihood of the spring beam 760 interfering withmovement of coil 120 through apparatus 740. In some alternativeembodiments, the spring beam 760 may have any other suitable shape.

Spring beam 760 may be configured to move, relative to cylindrical base750 and microcatheter 710, between an active position and a restposition. In the active position, an example of which is depicted inFIG. 8A, spring beam 760 may press its distal end 761 inwards towardinner lumen 756. In some embodiments, arrangement of the spring beam inthe active position may be achieved due to the shape-setting of torquepoles 754 a, 754 b to be twisted in a direction towards the inner lumenof the cylindrical base (i.e., in a “twisted configuration”). Forexample, as shown in FIG. 8B, torque poles 754 a, 754 b are twistedtowards inner lumen 756 (i.e., in a counterclockwise direction), whiletorque pole connection points 755 a, 755 b and the remainder ofcylindrical base 750 remain stationary. Because torque poles 754 a, 754b are shape-set in a twisted configuration, the torque poles apply atorque to spring beam 760 and, as a result, press spring beam distal end761 inward towards the inner lumen 756. As a result, when a coil 120extends from the distal end of cylindrical base 750 (such as in FIG.8A), spring beam 760 may press electrode 742 firmly against portion 824of the coil. When electrical current is applied to cylindrical base 750,electrode 742 may apply the electrical current to coil 120 and severcoil portion 824 that is in contact with electrode 742. As a result, thesegment of the coil that is distal to portion 824 may be separated fromthe remainder of the coil.

In the rest position, an example of which is depicted in FIG. 7A, theapplication of torque on spring beam 760 by torque poles 754 a, 754 bmay be reduced. In some embodiments, and as discussed in detail below,the reduction in torque may occur due to a phase change of cylindricalbase 750 that increases the pliability and elasticity of torque poles754 a, 754 b. As a result, the force pressing electrode 742 against coil120 may be minimized. In some embodiments, spring beam 760 may maintainlight contact with spring beam 760 in the rest position, such thatelectrode 742 is not firmly pressed against coil 120. Alternatively,spring beam 760 may be moved away from coil 120 such that electrode 742is held out of contact with coil 120. As a result, apparatus 740 and therest of microcatheter 710 may freely move in an axial or longitudinaldirection relative to coil 120 (and vice versa) while spring beam 760 isin the rest position, since the forceful contact between spring beam 760and coil 120 (which may impede axial advancement of apparatus 740) isminimized or completely removed. Similarly, microcatheter 710 andapparatus 740 may be advanced over a guidewire to a treatment site whilespring beam 760 is in the rest position, since spring beam 760 in therest position does not interfere with the guidewire or the axialadvancement of microcatheter 710.

As discussed above, coil-cutting apparatus 740 may be constructed fromNitinol and/or another shape-memory alloy, which exhibits two distinctphases: the martensite phase at lower temperatures, in which the alloymay be easily twisted or deformed, and the austenite phase at highertemperatures, in which the alloy returns to a pre-formed or “remembered”shape and becomes stiffer and more resistant to deformation. In someembodiments, coil-cutting apparatus 740 may be shape-set with torquepoles 754 a, 754 b in a twisted configuration (e.g., the configurationdepicted in FIG. 8B) and spring beam 760 in the active position. As aresult, apparatus 740 may be in a “soft” or relaxed state at lowtemperatures, allowing spring beam 760 to be moved to the rest positionso that a guidewire or coil 120 may be freely moved throughmicrocatheter 710 and cylindrical base 750. When a predeterminedtransformation temperature (e.g., austenite finish temperature) isreached, torque poles 754 a, 754 b may move to the shape-set twistedconfiguration, moving spring beam 760 into the active position andpressing electrode 742 against coil 120. Electrode 742 may then applycurrent to coil 120 in order to sever the coil at coil portion 824.Further, since electrode 742 is retained within microcatheter 710, thepatient's body is protected from inadvertent current application.

In some embodiments, the transformation temperature of coil-cuttingapparatus 740 (e.g., the austenite finish temperature) may be set to atemperature above body temperature. For example, the transformationtemperature may be within the range of 42° C. to 52° C. Apparatus 740may be more elastic and pliable in the “soft” or relaxed state below thetransformation temperature. For example, apparatus 740 may have aYoung's modulus of approximately 25 GPa in some embodiments of therelaxed state. In the relaxed state, torque poles 754 a, 754 b may beuntwisted (i.e., twisted away from inner lumen 756) such that the springbeam 760 may be held in the rest position. Because the transformationtemperature is above body temperature, spring beam 760 may remain in therest position while microcatheter 710 is delivered into the body andadvanced to the desired treatment site.

When a user desires to move spring beam 760 to the active position(e.g., to cut a treatment coil 120), a power source may be activated toapply electric current to cylindrical base 750 (e.g., via one or morewires connected to cylindrical base 750 and/or spring beam 760). Thesupplied current heats the Nitinol of apparatus 740 to a temperatureabove the transformation temperature, causing apparatus 740 to move tothe pre-set shape in which spring beam 760 is held in the activeposition. When a coil 120 extends from the distal end of cylindricalbase 750, electrode 742 is firmly pressed against coil 120 and appliescurrent to the coil, severing the coil at the coil section 824 which isin contact with electrode 742. Apparatus 740, including spring beam 760and torque poles 754 a, 754 b, may become increasingly stiff in theactive state above the transformation temperature (e.g., apparatus 740may have a Young's modulus of approximately 65 GPa in some embodimentsof the active state). In a manner similar to a leaf spring, spring beam760 may press electrode 742 against a coil 120 extending fromcylindrical base 750. As a result, stable contact may be maintainedbetween electrode 742 and coil 120 due to the stiffness of apparatus 740in the active state, providing a good electrical connection for cuttingthe coil 120 with apparatus 740.

Advantageously, coil-cutting apparatus 740 is configured to accommodateand cut endovascular coils of different sizes. The outer diameter ofendovascular coils typically used for aneurysm coiling come in a varietyof sizes and range in diameter from 0.25 mm to 0.37 mm. Coils ofdifferent sizes are frequently used during a single operation. Since theinner diameter of cylindrical base 750 is larger than the outer diameterof the largest sized coil used in the field (i.e., 0.37 mm),endovascular coils of any size may be delivered through system 700 to atreatment site. Further, since the forceful contact between spring beam760 and the coil is removed when in the rest position, the coil may passthrough coil-cutting apparatus 740 without interference from the springbeam distal end 761 or any other part of the spring beam 760. Whenelectric current is applied to apparatus 740 to cut the coil, springbeam 760 is shape-set to move inward until electrode 742 contacts thecoil and applies current to the coil. Thus, apparatus 740 is configuredto cut endovascular coils of any size, since spring beam 760 isshape-set to contact even coils having the smallest diameter (i.e., 0.25mm coils). As a result, system 700 may be used for the delivery of coilshaving any diameter, or alternatively, for the delivery of coils ofmultiple sizes during a single operation.

FIGS. 9A-9D depict an exemplary method of delivering and cutting anendovascular coil 120 with an exemplary coil-cutting apparatus describedherein. Although FIGS. 9A-9D depict the use of system 700 to deliver andcut coil 120, any exemplary coil-cutting system and apparatus disclosedherein may be used for the delivery and cutting of an endovascular coilaccording to the method depicted in FIGS. 9A-9D.

In FIG. 9A, microcatheter 710 with coil-cutting apparatus 740 at itsdistal end is advanced (e.g., over a guidewire) through a blood vessel980 to a treatment site, such as aneurysm 982. During delivery of themicrocatheter, spring beam 760 of the coil-cutting apparatus may be heldin the rest position to avoid interference with the guidewire. In FIG.9B, once apparatus 740 is positioned in the aneurysm interior 984, anendovascular coil 120 of a desired size is advanced from system 700 intothe aneurysm to fill it. Spring beam 760 of the coil-cutting apparatusmay continue to be held in the rest position so that the spring beam 760does not interfere with the axial movement of the coil 120.

When a desired length of coil 120 has been delivered into aneurysm 982(FIG. 9C), the power source of system 700 may be activated to movespring beam 760 to the active position, thus cutting the coil portion824 in contact with electrode 742 (FIG. 9D). As a result, the section ofcoil 120 that is distal to portion 824 may remain within aneurysm 982while the rest of the coil is removed. The coil advancement and cuttingsteps of FIGS. 9B-9D may be repeated as needed with coils of the same ordifferent size until the aneurysm interior 984 is filled. Microcatheter710 and coil-cutting apparatus 740 may then be removed from aneurysm 982and vessel 980.

FIGS. 10A-10C illustrate another exemplary system 1000 for deliveringand cutting an endovascular coil, having a coil-cutting apparatus 1040connected to the distal end of microcatheter 710. Coil-cutting apparatus1040 may include a spring beam 1060 having a widened portion 1065 at thesection of the spring beam 1060 containing electrode 1042. Widenedportion 1065 may be situated in the middle of spring beam 1060 (alongthe longitudinal Z-direction); the spring beam 1060 may have a largerwidth at widened portion 1065 than at proximal end 1062 or distal end1061.

FIG. 10B depicts coil-cutting apparatus 1040 with spring beam 1060 in arest position, in which spring beam 1060 (including electrode 1042) isheld away from coil 120. FIG. 10C depicts coil-cutting apparatus 1040with spring beam 1060 in an active position. In some embodiments, springbeam 1060 may move into the active position when electrical current isapplied to cylindrical base 750 (or any other suitable portion ofcoil-cutting apparatus 1040), heating cylindrical base 750 and causingtorque poles 754 a, 754 b to move into their respective shape-set,twisted configuration (represented by the dot-dash rotational arrow inFIG. 10C). The torque pole twisting may cause spring beam proximal end1062 to pivot away from the rest of cylindrical base 750 (thus wideningslit 752), thus angling spring beam 1060 towards coil 120 untilelectrode 1042 contacts coil 120. Electrode 1042 may apply electricalcurrent to coil 120 in order to sever the distal portion of coil 120from the remainder of the coil 120.

FIG. 11 depicts an exemplary method of manufacturing an apparatus forcutting an endovascular coil. One of ordinary skill will understand thatthe method of manufacturing disclosed herein may be used to manufactureany suitable apparatus for cutting an endovascular coil, including andnot limited to apparatus 740 and apparatus 1040.

In step 1102, the method of manufacturing may include providing acylindrical base having a proximal end, a distal end, and at least oneinner lumen. The cylindrical base may have an annular or ellipticalcross-sectional shape and may be constructed at least partially of ashape-memory alloy such as Nitinol. In some embodiments, the cylindricalbase may be shaped and configured for placement within, and connectionto, the distal end of a microcatheter. Examples of a cylindrical baseprovided in step 1102 include cylindrical base 750 and cylindrical base1050.

In step 1104, the method of manufacturing may include forming, at thedistal end of the cylindrical base, an elongated spring beam extendingfrom the distal end of the cylindrical base. The spring beam may beformed, such as by laser cutting from a tube constructed of ashape-memory alloy such as Nitinol. In some embodiments, the spring beammay be formed from the same tube as the cylindrical base, such that thespring beam and cylindrical base may be constructed as a single, unitarystructure. In alternative embodiments, the spring beam and thecylindrical base may be constructed from separate tubes and connectedvia adhesive, welding, soldering, or other suitable techniques. Examplesof an elongated spring beam formed in accordance with step 1104 includespring beam 760 and spring beam 1060.

In step 1106, the method of manufacturing may include forming acircumferential slit in a distal portion of the cylindrical base. Theslit may be formed by laser cutting or other known techniques and mayextend through the side wall of the cylindrical base, passing betweeninner and outer surfaces of the cylindrical base. In some embodiments,the slit may be situated a distance within the range of 0.1 mm to 0.3 mmfrom the distal end of the cylindrical base. Additionally, oralternatively, the slit may extend along a portion of the circumferenceof the cylindrical base, such that the slit does not extend into anotherportion of the cylindrical base. Examples of a circumferential slitformed in accordance with step 1106 include slit 752 and slit 1052.

In step 1106, formation of the circumferential slit may produce at leastfirst and second torque poles connecting the spring beam to thecylindrical base. In some embodiments, the first and second torque polesmay form a continuous, arc-shaped structure adjacent to the slit, with aproximal end of the elongated spring beam connected to the middle of thecontinuous, arc-shaped structure. The torque poles may be constructedfrom the same material as the cylindrical base (i.e., Nitinol or anothershape-memory alloy). In some embodiments, the torque poles may beconfigured (due, at least in part, to their shape memory properties) toundergo a phase transformation at a predetermined transformationtemperature, above which the torque poles may move into a pre-formed or“remembered” shape and become increasingly resistant to deformation.Examples of first and second torque poles formed in accordance with step1106 include torque poles 754 a and 754 b, respectively, and torquepoles 1054 a and 1054 b, respectively.

In step 1108, the method of manufacturing may include shape-setting thefirst and second torque poles in a twisted configuration. For example,according to embodiments in which the torque poles are constructed fromNitinol or another shape memory alloy, step 1108 may includeshape-setting the torque poles in the twisted configuration such thatthe twisted configuration is the “remembered” shape of the torque poles.In some embodiments, the transformation temperature of the torque poles(above which the torque poles move into the “remembered” twistedconfiguration) may be set to a temperature above body temperature. Forexample, the transformation temperature of the torque poles may bewithin the range of 42° C. to 52° C. However, at temperatures below thetransformation temperature, the first and second torque poles becomemore pliable and easily deformed. Thus, in some embodiments, the torquepoles may be configured to assume a relaxed configuration attemperatures below the transformation temperature; in the relaxedconfiguration, the torque poles may be straightened relative to thetwisted configuration (i.e., a degree of twisting of the torque polesmay be reduced). Examples of the twisted configuration of step 1108 mayinclude the torque pole configurations depicted in FIGS. 8A-8B and inFIG. 10C, while examples of the relaxed configuration may include thetorque pole configurations depicted in FIGS. 7A-7B and in FIG. 10B.

In some embodiments, the torque poles may be shape-set to be twisted ina direction towards the inner lumen of the cylindrical base. Forexample, in the exemplary twisted configuration depicted in FIG. 8B, themiddle portion of torque poles 754 a, 754 b (including the portion wherethe spring beam proximal end 762 is connected) may be twisted inrotational direction towards inner lumen 756, as represented by thedot-dash arrow in FIG. 8B; meanwhile, connection points 755 a and 755 bmay remain fixed to cylindrical base 750. As a result, when thecylindrical base is heated to a temperature equal to or greater than thetransformation temperature, e.g., due to the application of electriccurrent, the torque poles may move into the “remembered” twistedconfiguration.

In some embodiments, the first and second torque poles may be configuredto hold the spring beam in a first position when the first and secondtorque poles are in the twisted configuration. Examples of the firstposition may include the active positions depicted in FIGS. 8A-8B and10B, in which the twisting of the torque poles moves the distal end ofthe spring beam inward towards the inner lumen of the cylindrical base.Additionally, or alternatively, the first and second torque poles may beconfigured to hold the spring beam in a second position, different fromthe first position, when the first and second torque poles are in therelaxed configuration. Examples of the second position may include therest position depicted in FIGS. 7A-7B, in which the spring beam is heldaway from the center of the inner lumen of the cylindrical base. As aresult, a coil extending from the cylindrical base is not contacted bythe electrode on the spring beam when the torque poles hold the springbeam in the second position.

In some embodiments, step 1108 may additionally include shape-settingthe elongated spring beam to have a desired shape. For example, thespring beam may be shape-set to be curved or arc-shaped, such that thespring beam has a convex shape relative to the inner lumen of thecylindrical base (i.e., the proximal and distal ends of the spring beammay point away from the inner lumen of the cylindrical base). At leastone electrode may be situated at the apex of the curved or arched springbeam, such that the electrode may be pushed against an endovascularcoil, and apply electrical current to the endovascular coil, when thecylindrical body is heated, and the torque poles moved into the twistedconfiguration. In some embodiments, shape-setting the first and secondtorque poles may be performed simultaneously with shape-setting thespring beam; alternatively, shape-setting the first and second torquepoles may be performed before or after the shape-setting of the springbeam. Examples of shape-set spring beams include the curved shapes ofspring beams 760 and 1060.

In some embodiments, a coil-cutting apparatus manufactured in accordancewith the method of FIG. 11 may be situated at least partially within thedistal end of a microcatheter (e.g., microcatheter 710 or 1010) andconnected thereto. For example, an outer surface of the cylindrical basemay be connected directly to the inner wall of the microcatheter byadhesive, welding, soldering, or other suitable techniques. In someembodiments, the coil-cutting apparatus may be arranged relative to themicrocatheter such that the distal end of the spring beam is even orsubstantially even with the distal-most end of the microcatheter.Alternatively, the distal end of the spring beam may be located in aproximal direction from the distal-most end of the microcatheter.Advantageously, this configuration allows the coil-cutting apparatus andmicrocatheter to be advanced together through the patient's body and toa treatment site. Additionally, placement of the coil-cutting apparatusentirely within the microcatheter prevents contact between the patient'sbody and the at least one electrode on the spring beam.

FIG. 12A is a side view and FIG. 12B is an interior view of anendovascular device 1200 configured for delivery of an endovascularinstrument 1220, consistent with disclosed embodiments. The endovasculardevice 1200 may include an elongated sheath 1210 (e.g., amicrocatheter). The endovascular device 1200 may include at least oneelectrode 1242 and 1244. FIG. 14 is a perspective side view of anelongated sheath 1210 of the endovascular device 1200 of FIGS. 12A and12B, consistent with disclosed embodiments. In FIG. 14, one electrode1242 may be connected via an embedded wire 1243 to the distal end of thesheath 1210. Additionally, or alternatively, as shown in FIG. 13, asecond electrode 1244 may be connected to the distal end of an outersheath 1230 of endovascular device 1200. As shown in FIGS. 22A-22F, theendovascular instrument 1220 (e.g., an endovascular coil) may bedelivered into a hollow body structure 2282 (e.g., an aneurysm). Forexample, endovascular instrument 1220 may be delivered through an innerlumen 1214 of the endovascular device 1200 into the hollow bodystructure 2282 in order to permanently implant the endovascularinstrument 1220 within the hollow body structure, such that instrument1220 fills an interior space 2284 of the hollow body structure in orderto block blood flow into the hollow body structure and induce bloodclotting in the hollow body structure, so that the structure does notrupture.

FIGS. 12A and 12B illustrate an example of the endovascular device 1200with a pair of electrodes 1242, 1244 configured to selectively deliveran electric current through a segment of the endovascular instrument1220 within the inner lumen 1214 of the elongated sheath 1210. FIG. 12Balso depicts a constrictor 1260 (e.g., a balloon) configured to narrowthe inner lumen 1214 of the sheath. FIG. 17A depicts an embodiment inwhich constrictor 1260 selectively moves at least one of the electrodes1242 and 1244 relative to a segment of the endovascular instrument 1220so that a section 1724 of the endovascular instrument 1220 comes intocontact with the at least one electrode.

FIGS. 18A and 18B depict an endovascular instrument 1220 being severedby the electrode pair 1244, 1242 of the endovascular device 1200 ofFIGS. 12A and 12B, consistent with disclosed embodiments. FIGS. 18A and18B depict a severed section 1826 of the instrument released from theremainder of the instrument and from device 1200, while a residualsection 1828 of the instrument remains within the endovascular device1200 after the electrodes 1242 and 1244 selectively deliver the electriccurrent through the segment 1724 of the endovascular instrument 1220.

As shown in FIG. 22F, in some embodiments the endovascular device 1200may be removed from the body, leaving endovascular instrument 1220configured as an embolic mass 2275 implanted within the hollow bodystructure 2282.

FIG. 16A is an interior view of a distal section 1213 a of theendovascular device 1200 of FIGS. 12A and 12B in an unconstricted state,consistent with disclosed embodiments. FIGS. 16B and 16C depictcross-sectional views of the endovascular device 1200 of FIG. 16A in theunconstricted state, consistent with disclosed embodiments. FIG. 17A isan interior view of the distal section 1213 a of the endovascular device1200 of FIGS. 12A and 12B in a constricted state, consistent withdisclosed embodiments. FIGS. 17B and 17C depict cross-sectional views ofthe endovascular device 1200 of FIG. 17A in the constricted state,consistent with disclosed embodiments. As shown in FIG. 17A, constrictor1260 may be configured to reduce the size of inner lumen 1214, thusmoving instrument 1220 into contact with the electrode pair 1242 and1244.

“Coil embolization” is a technique for treating aneurysms by filling theaneurysm with a series of metallic coils in order to block blood flowand prevent rupture of the aneurysm or to induce blood clotting in theaneurysm to thereby block blood flow. First, a framing coil may beinserted; the framing coil is the most rigid and often the largest coiland is configured to fill the aneurysm and create a stabilizing frame tobe filled with subsequent coils. Then, the remaining space inside theaneurysm is filled using softer, usually smaller coils, such as fillingcoils and/or finishing coils. Each coil must be delivered one-by-one tothe treatment site, extending the duration of the entire operation.Moreover, the length of the coils must be selected beforehand to ensurethat the aneurysm is completely filled but not over-packed. Selecting acoil that is too long may require retraction of the entire coil from thebody (for replacement with a shorter coil), while selecting a coil thatis too short may require usage of additional coils.

Endovascular devices disclosed herein may allow a desired length of coilor any other endovascular instrument to be advanced into an aneurysm andthen severed with a partitioning mechanism (e.g., an electrode pair), sothat the advanced coil length is detached from the rest of the coil.Endovascular instruments (e.g., coils) also disclosed herein may beconfigured to be delivered into a hollow body structure with theaforementioned endovascular devices. For example, endovascular coils mayhave multiple regions that are each configured as a different “type” ofcoil (e.g., a framing coil region and a filling coil region), yet whichare part of a single, continuous structure. Each region of the coil maybe delivered into the aneurysm and then cut away, after which the tip ofthe delivery tool can be moved to another area to immediately begindelivery of the next region of coil. Advantageously, the aneurysm may befilled much more quickly since time is not spent passing individualcoils from outside the body to the treatment site. Further, since theexact length of coil that is desired by the operator may be delivered,the risks associated with under-packing or over-packing an aneurysm maybe avoided.

Aspects of this disclosure may relate to an endovascular instrument forfilling a hollow body structure. In some embodiments, the endovascularinstrument described below may be configured to be delivered to atreatment site within a body by an example of an endovascular devicedisclosed herein. However, the endovascular instrument described belowmay additionally or alternatively be configured to be delivered by anysuitable delivery means known in the art (e.g., delivery catheters andsheaths).

Consistent with disclosed embodiments, an endovascular instrument mayrefer to any device or instrument configured to be placed within or tooperate within a blood vessel, such as during endovascular surgeries andprocedures. Some non-limiting examples of endovascular instruments mayinclude catheters, balloon catheters, stent grafts, stents, guidewires,coils, endovascular revascularization devices, embolization devices, orany other device or instrument configured to be placed within a bloodvessel in a body.

As described above, the endovascular instrument may be configured forfilling a hollow body structure. As used herein, a hollow body structuremay refer to any structure within a body that encloses, either partiallyor entirely, an interior volume. A hollow body structure may refer to ananatomical feature, such as an aortic aneurysm, cerebral aneurysm,popliteal artery, ventricular aneurysm, blood vessel, esophagus,stomach, small intestine, gallbladder, fallopian tubes, or urinarybladder. As used herein, filling a hollow body structure may includeplacing at least one device or material (e.g., the endovascularinstrument) within the interior volume of the hollow body structure.Filling the hollow body structure may include either filling theentirety of the interior volume or a fraction of the interior volume.For example, the endovascular instrument described herein may beconfigured for filling the entire interior volume within the hollow bodystructure, such that no free or un-filled areas remain within the hollowbody structure. In some embodiments, the at least one device or materialused for filling the hollow body structure may be delivered from outsidethe body to the interior of the hollow body structure.

FIG. 20A depicts a first example of an endovascular instrument 1220configured for filling a hollow body structure, and FIG. 21A depicts asecond example of an endovascular instrument 1220 a configured forfilling a hollow body structure. In some embodiments, instruments 1220and 1220 a may include endovascular coils configured for filling theinterior volume of aneurysms and other hollow body structures. However,persons of ordinary skill will understand that endovascular instrumentsdescribed herein are not limited to endovascular coils. FIGS. 22A-22Fdepict a process for delivering an example of an endovascular instrument1220 through a blood vessel 2280 and into a hollow body structure 2282(e.g., an aneurysm) using an endovascular device 1200 (note thatinstrument 1220 a may similarly be configured for delivery into ananeurysm using endovascular device 1200). Although the example of FIGS.22A-22F depict the delivery of endovascular instrument 1220 into ahollow body structure 2282 (e.g., an aneurysm), instrument 1220 mayadditionally or alternatively be delivered into other hollow bodystructures.

As shown, instrument 1220 may be delivered through an inner lumen ofdevice 1200 from an area outside the patient's body to the interiorvolume of the aneurysm. As shown in FIGS. 22B-22F, the length ofendovascular instrument 1220 may be passed into hollow body structure2282 using device 1200 until the entire inner volume of the aneurysm isfilled with the instrument (i.e., until no additional length ofinstrument can be delivered into the aneurysm without over-packing it).As also shown in FIGS. 22B-22F, endovascular instrument 1220 may besevered with endovascular device 1200 when the aneurysm is filled anddevice 1200 may then be removed from the body, leaving instrument 1220within the aneurysm.

Consistent with disclosed embodiments, the endovascular instrument mayinclude an elongated member. As used herein, an elongated member mayrefer to any long, thin structure configured to be arranged in a desiredshape or three-dimensional arrangement. For example, the elongatedmember may be configured to be arranged in a helically-coiled shape(i.e., continuous, regularly-spaced rings of consistent diameter orvariable diameter). Some non-limiting examples of elongated members mayinclude wires, fibers, tubing, sheaths, catheters, guidewires, or anyother suitable device or instrument. Consistent with disclosedembodiments, the elongated member may be configured to be wound into ahelical coil and may exhibit differing coiling properties along a lengthof the elongated member. As used herein, coiling properties may refer tothe physical parameters of the coil formed from the elongated member.Some non-limiting examples of coiling properties may include coil pitch(i.e., the space between adjacent windings or rings), wire diameter,outer diameter of the coil, coil angle, and free length (i.e., the axiallength of each distinct section of the coil). Thus, the elongated memberof the endovascular instrument may be configured to be wound into acoil, and one or more coiling properties may have different values indifferent sections along the length of the coil.

Consistent with disclosed embodiments, the elongated member may includea first region and a second region proximal to the first region. As usedherein, a first region and second region of the elongated member mayrefer to two separate segments along the length of the elongated member.As used herein, the term “proximal” may refer to a location closer tothe user or operator of the elongated member (e.g., a physician), whilethe term “distal” may refer to a location closer to the treatmentlocation within the patient. Thus, the second region of the elongatedmember may be closer to the user of the elongated member, while thefirst region may be further from the user. In some embodiments, thefirst region of the elongated member may be the distal-most portion ofthe elongated member (i.e., the first region may include the distal tipof the elongated member). Alternatively, the first region may includesome other portion of the elongated member. In some embodiments, theelongated member may include only the first region and second region(that is, the first and second regions may encompass the entireelongated member). In alternative embodiments, the elongated member mayinclude one or more additional regions, such as a third region, fourthregion, etc.

In some embodiments, the first region may be integrally connected to thesecond region. As used herein, integrally connected may mean that thesecond region may be immediately adjacent to the first region.Alternatively, the second region may be spaced apart from the firstregion. For example, the elongated member may include one or moreregions located in between the first region and second region.Consistent with disclosed embodiments, the elongated member may includea third region positioned between the first region and the secondregion. At least one structural property of the elongated member, asdiscussed above, may differ between the first region, the second region,and the third region. That is, the elongated member of the endovascularinstrument may be configured to be wound into a coil, and one or morecoiling properties (e.g., coil pitch, wire diameter, outer diameter ofthe coil, coil angle, and free length) may have different values in thefirst region, the second region, and the third region of the elongatedmember. In some embodiments, one or more additional regions (e.g., afourth region) may also be positioned between the first region andsecond region.

In the example shown in FIG. 20A, endovascular instrument 1220 mayinclude three separate regions: a distal segment 2070 (which may be anexample of a first region of the elongated member), a middle segment2072 (which may be an example of a third region of the elongatedmember), and a proximal segment 2074 (which may be an example of asecond region of the elongated member), each of which may be configuredto have different coiling properties. However, endovascular instrumentsdisclosed herein may alternatively include one segment, two segments,four segments, five segments, or any other suitable number of segments,each having different coiling properties. In the example depicted inFIG. 20A, the coil pitch may vary along the length of the elongatedmember of instrument 1220, with distal segment 2070 having the smallestpitch and proximal segment 2074 having the largest pitch. Additionally,or alternatively, proximal segment 2074 may have a smaller outerdiameter than the distal segment 2070 and middle segment 2072.

In the example shown in FIG. 21A, endovascular instrument 1220 a mayinclude two separate regions: a distal segment 2070 (which may be anexample of a first region of the elongated member) and a proximalsegment 2074 a (which may be an example of a second region of theelongated member), both of which may be configured to have differentcoiling properties. In the example depicted in FIG. 21A, distal segment2070 may have a smaller coil pitch and a larger outer diameter thanproximal segment 2074 a.

Consistent with disclosed embodiments, the first region and the secondregion of the elongated member may be interconnected. As used herein,interconnected may mean that the first region and second region are partof a single, continuous structure. Optionally, the first region andsecond region may be interconnected with additional regions of theelongated member (e.g., a third region, a fourth region, etc.). In someembodiments, the elongated member may be manufactured as a single,unitary piece such that the elongated member portion within the firstregion is part of the same structure as the elongated member portionwithin the second region. For example, in embodiments in which theelongated member is formed from one or more wires wound into a coil, thesame one or more wires may pass through the first region and the secondregion of the elongated member, with the wires configured to exhibitdifferent coiling properties in the first region and second region, asdiscussed above. In alternative embodiments, the portions of theelongated member corresponding to the first region and second region maybe manufactured separately and joined together using known means, suchas welding, adhesive, mechanical connectors, or other suitable means.

In the example of FIG. 20A, distal segment 2070, middle segment 2072,and proximal segment 2074 of endovascular instrument 1220 may beinterconnected as parts of a single, continuous structure. In order toseparate these segments of instrument 1220, endovascular device 1200(which may be configured to deliver instrument 1220 to a treatment site)may include a partitioning mechanism configured to sever endovascularinstrument 1220 while device 1200 is positioned within the body of thepatient; the segments of endovascular instrument 1220 may be separatedusing the partitioning mechanism, e.g., during a medical operation orprocedure. Additionally, or alternatively, endovascular instrument 1220may include at least one coil detachment mechanism (discussed in detailbelow) located at the junction between distal segment 2070 and middlesegment 2072 and/or at the junction between middle segment 2072 andproximal segment 2074. The at least one coil detachment mechanism may beactuated to separate the regions of endovascular instrument 1220. In theexample of FIG. 21A, distal segment 2070 and proximal segment 2074 a ofendovascular instrument 1220 a may similarly be interconnected as partsof a single, continuous structure and may similarly be configured to beseparated via, e.g., a partitioning mechanism and/or a coil detachmentmechanism.

Consistent with disclosed embodiments, the first region and the secondregion of the elongated member may be configured to bend in a firstmanner and a second manner, respectively. As used herein, bending of theelongated member may refer to a transition from a firstthree-dimensional arrangement of the elongated member to a second,different three-dimensional arrangement; the elongated member may beconfigured to bend due to structural or material properties of theelongated member, a change in the environment surrounding the elongatedmember, the application of an external force, and/or the removal of anexternal force. Some non-limiting examples of bending of the elongatedmember include a transition of the elongated member from a straightenedor linear state to a curved or non-linear state; a transition of theelongated member from a curved or non-linear state to a straightened orlinear state; and a transition of the elongated member from a firstcurved or non-linear state to a second, different curved or non-linearstate. In some embodiments, bending of the elongated member may occurwhen a restraining force is removed from the elongated member (e.g.,when the elongated member is released from a delivery device) and theelongated member moves into a specific three-dimensional arrangement orshape based on structural and/or material properties of the elongatedmember. In some embodiments, bending of the elongated member, includingbending of the first region and second region in the first manner andsecond manner, respectively, may occur when the elongated member isexposed to a liquid or is exposed to a particular liquid (such asblood). In some examples, bending of the elongated member may occur inreaction to the elongated member being exposed to a liquid or is exposedto a particular liquid (such as blood).

Consistent with disclosed embodiments, the first region of the elongatedmember may be configured to bend in the first manner within the hollowbody structure to form a stabilizing frame. For example, the firstregion may be configured to be delivered into the hollow body structurein a straightened or linear delivery state (e.g., within a deliverydevice) and may bend to form the stabilizing frame when the first regionis within the hollow body structure (e.g., when the first region isreleased from the delivery device). The first region may be configuredto bend in the first manner while the first region is interconnectedwith other regions of the endovascular instrument. Additionally, oralternatively, the first region may be configured to bend in the firstmanner after the first region has been separated from the rest of theendovascular instrument (e.g., by a partitioning mechanism and/or by acoil detachment mechanism, as described herein). In some embodiments,the first region of the elongated member may be configured to bend inthe first manner within the hollow body structure to form a stabilizingframe in reaction to an exposure to blood in the hollow body structureand/or in reaction to a restraining force being removed from the firstregion of the elongated member (e.g., when the first region of theelongated member is released from a delivery device into the hollow bodystructure).

As used herein, a stabilizing frame may refer to a structure configuredto contact and support the inner wall of the hollow body structure. Insome embodiments, the stabilizing frame may be a hollowthree-dimensional structure into which additional filling devices ormaterial may be placed; examples of the three-dimensional structure mayinclude a sphere, a basket, a cage, or another complex three-dimensionalshape. In a non-limiting example, the first region of the elongatedmember may be configured as a framing coil. As used herein, a framingcoil may be a first coil segment delivered into a hollow body structure,such as an aneurysm, and may bend to form a stabilizing frame configuredto support the hollow body structure and within which additional coilsmay be placed in order to fill the hollow body structure. Thus, when thefirst region of the elongated member is placed within a hollow bodystructure, the first region may be configured to bend to form astabilizing frame configured to support the hollow body structure andwithin which additional coils may be placed in order to fill the hollowbody structure.

FIGS. 20A and 20B depict an example of an endovascular instrument 1220including a distal segment 2070, which may be an example of the firstregion of the elongated member, discussed above. FIG. 20A shows distalsegment 2070 of the elongated member in a linear state; in someembodiments, distal segment 2070 may be arranged in the linear state ofFIG. 20A when a restraining force is applied thereto (e.g., when distalsegment 2070 is restrained within a delivery device). FIG. 20B showsdistal segment 2070 of the elongated member bent in the first manner toform stabilizing frame 2071, which may include a three-dimensionalstructure having interior space 2071 a configured to receive additionalfeatures therein, such as middle segment 2072 and proximal segment 2074of the elongated member. In some embodiments, distal segment 2070 may bebiased to bend into the shape of stabilizing frame 2071 when arestraining force is removed from the distal segment (e.g., when distalsegment 2070 is released from a delivery device). As discussed above,distal segment 2070 may be configured to bend into the frame of FIG. 20Bwhile distal segment 2070 is interconnected with the other regions ofendovascular instrument 1220 and, additionally or alternatively, whendistal segment 2070 has been separated from the rest of endovascularinstrument 1220.

In some embodiments, distal segment 2070 may be configured as a framingcoil and may bend to form stabilizing frame 2071 when the distal segmentis delivered into an aneurysm. As shown in FIGS. 22B-22C, when distalsegment 2070 is released from endovascular device 1200 into hollow bodystructure 2282 (e.g., an aneurysm), the distal segment may bend to formstabilizing frame 2071, which may contact and support the inner wall ofhollow body structure 2282. In some embodiments, distal segment 2070 maybe severed from the rest of endovascular instrument 1220 (e.g., by apartitioning mechanism) and may remain within hollow body structure 2282as a stabilizing frame. As shown in FIGS. 22C-22E, stabilizing frame2071 may have a hollow three-dimensional shape such that additional coilmaterial, including the remaining regions of endovascular instrument1220, may be delivered into the interior spaces 2071 a of thestabilizing frame so that the entire inner volume 2284 of the aneurysmmay be filled.

Consistent with disclosed embodiments, the second region of theelongated member may be configured to bend, after formation of theframe, in a second manner substantially within the frame. As usedherein, bending substantially within the frame may refer either to astate in which the second region is situated entirely within the framewhen the second region is bent in the second manner, or to a state inwhich the majority of the second region is situated within the framewhen the second region is bent in the second manner, with the remainderof the second region being positioned outside the frame but within thehollow body structure. For example, the second region of the elongatedmember may be configured to be delivered into the hollow body structurein a straightened or linear delivery state (e.g., within a deliverydevice) and may bend in the second manner when the second region isreleased from the delivery device and placed substantially within theinterior volume of the frame. In some embodiments, the second region maybe configured to bend in the second manner while the second region isinterconnected with other regions of the endovascular instrument.Additionally, or alternatively, the second region may be configured tobend in the second manner after the second region has been separatedfrom the rest of the endovascular instrument (e.g., by a partitioningmechanism and/or by a coil detachment mechanism, as described herein).Additionally, or alternatively, the second region may be partitionedinto multiple portions, each of which may be configured to bend in thesecond manner. In some embodiments, the second region of the elongatedmember may be configured to bend in the second manner substantiallywithin the frame in reaction to an exposure to blood in the hollow bodystructure and/or in reaction to a restraining force being removed fromthe second region of the elongated member (e.g., when the second regionof the elongated member is released from a delivery device).

In the embodiment of FIGS. 20A and 20B, proximal segment 2074 may be anexample of the second region of the elongated member. FIG. 20A showsproximal segment 2074 in a linear state; in some embodiments, proximalsegment 2074 may be arranged in the linear state of FIG. 20A when arestraining force is applied thereto (e.g., when proximal segment 2074is restrained within a delivery device). FIG. 20B shows proximal segment2074 bent in the second manner into a three-dimensional structure, suchas a helix, a sphere, a convex three-dimensional shape, or a concavethree-dimensional shape. In some embodiments, proximal segment 2074 maybe biased to bend in the second manner when a restraining force isremoved from the proximal segment (e.g., when proximal segment 2074 isreleased from a delivery device). As discussed above, segment 2074 maybe configured to bend in the second manner while interconnected with theother regions of endovascular instrument 1220 and, additionally oralternatively, when separated from the rest of endovascular instrument1220. Proximal segment 2074 may also be configured to be partitionedinto multiple sections, each of which may be configured to bend in thesecond manner. Additionally, in the embodiment of FIGS. 21A and 21B,proximal segment 2074 a may be another example of the second region ofthe elongated member. Proximal segment 2074 a may similarly beconfigured to bend in the second manner into a three-dimensionalstructure, such as a helix, as shown in FIG. 21B, or a sphere.

Consistent with disclosed embodiments, the second region of theelongated member may be configured to bend in the second manner to forma curved mass substantially within the frame. As used herein, a curvedmass may include a structure formed from one or more pieces of theelongated member which are bent, twisted, or otherwise arranged to fillthe interior volume of the stabilizing frame and, in some cases,portions of the hollow body structure outside of the stabilizing frame.As discussed above, the second region may be configured to assume aparticular three-dimensional shape when removed from the deliverydevice, such as a helix, a sphere, a convex three-dimensional shape, aconcave three-dimensional shape, or another three-dimensional shape. Insome embodiments, the curved mass may be formed from a single,continuous piece of the second region bending in the second manner whenit is delivered into the stabilizing frame; this piece of the secondregion may include the entire second region or a portion of the secondregion. In alternative embodiments, the second region may be severed inmultiple pieces (as discussed in detail below), which may be deliveredinto the stabilizing frame to form the curved mass. As used herein, thecurved mass being substantially within the frame may refer either to astate in which the curved mass is situated entirely within the frame, orto a state in which the majority of the curved mass is situated withinthe frame with the remainder of the curved mass being positioned outsidethe frame but within the hollow body structure.

In some embodiments, the second region of the elongated member may beconfigured as a filling coil. As used herein, a filling coil may be anendovascular coil configured for delivery into the aneurysm after theframing coil to promote thrombus formation; as a filling coil, thesecond region may be caged within the stabilizing frame. For example, inthe above-discussed embodiments in which the elongated member includes athird region positioned between the first region and the second region,the second region may constitute a finishing coil and the third regionmay constitute a filling coil.

FIGS. 21A and 21B illustrate an example in which first region 2070 maybe configured as a framing coil and second region 2074 a may beconfigured as a filling coil. As discussed above, first region 2070 andsecond region 2074 a may be integrally formed as a single structure andmay be configured to be detached from each other, such as with apartitioning mechanism (discussed in further detail below). As alsodiscussed above, at least one coiling property may differ between thefirst region 2070 and second region 2074 a; for example, first region2070 may have a smaller pitch and a larger outer diameter than secondregion 2074 a.

As shown in FIGS. 22B-22C, first region 2070 may be delivered first intothe hollow body structure and may bend within the hollow body structureto form the stabilizing frame 2071. First region 2070 may be detachedfrom the remainder of elongated instrument 1220 a (i.e., from secondregion 2074 a) before, during, or after the first region completes thebending into stabilizing frame 2071. As shown in FIGS. 22C-22E, secondregion 2074 a (which may be configured as a filling coil) may then bedelivered into the interior of stabilizing frame 2071 in one piece or inmultiple pieces and may be caged substantially within the stabilizingframe, bending within the interior volume of the stabilizing frame toform a curved mass 2273. Optionally, remaining space within hollow bodystructure 2282 may be filled with one or more finishing coils. As shownin FIGS. 22E-22F, endovascular device 1200 may be removed from the body,leaving the delivered pieces of coil 1826 within hollow body structure2282 in an embolic mass 2275 that is configured to block blood flow intothe hollow body structure 2282 or to induce blood clotting in the hollowbody structure 2282.

In alternative embodiments, the second region of the elongated membermay be configured as a finishing coil. As used herein, a finishing coilmay be an endovascular coil configured to compact and fill remainingspace within the aneurysm to increase occlusion, prevent catheterkickbacks, and prevent coil migration; as a finishing coil, the secondregion may be inserted into the aneurysm after a framing coil and one ormore filling coils and may be softer than filling coils used in theprocedure.

FIGS. 20A and 20B illustrate an example in which the first region 2070may be configured as a framing coil, the third region 17154 (i.e., themiddle segment) may be configured as a filling coil, and the secondregion 17156 (i.e., the proximal segment) may be configured as a fillingcoil. As discussed above, first region 2070, third region 17154, andsecond region 2074 may be integrally formed as a single structure andmay be configured to be detached from each other, such as with apartitioning mechanism (discussed in further detail below). As alsodiscussed above, at least one coiling property may differ between thefirst region 2070, third region 17154, and second region 2074. Forexample, second region 2074 may be configured as a finishing coil,having a larger pitch and a smaller outer diameter than the othersegments of endovascular instrument 1220 such that the second region2074 may be the softest portion of instrument 1220.

First region 2070 (configured as a framing coil) and third region 2072(configured as a filling coil) may be delivered first into the hollowbody structure in the manner discussed above for FIGS. 21A-21B. Secondregion 2074 (when configured as a finishing coil) may then be deliveredto compact the other coils and fill remaining space within hollow bodystructure 2282 (e.g., an aneurysm), such that the inner volume 2284 ofthe aneurysm may be filled. In some embodiments, second region 2074 maybend in a three-dimensional shape to fill space within the stabilizingframe, thus forming a curved mass substantially within the frame.

Consistent with disclosed embodiments, the elongated member may beconfigured to block blood flow into the hollow body structure. Forexample, and as discussed above, the first region of the elongatedmember may bend within the hollow body structure to form the stabilizingframe and the second region of the elongated member may then form thecurved mass substantially within the frame. The stabilizing frame, withthe curved mass therein, may fill at least a portion or the majority ofthe interior volume of the hollow body structure. Optionally, remainingspace within the hollow body structure may be filled with at least oneadditional portion of the elongated member (e.g., a portion of theelongated member configured as a finishing coil). Additionally, oralternatively, the elongated member within the hollow body structure mayinduce blood clotting in the hollow body structure, and thereby blockblood flow into the hollow body structure. The resulting structure maytightly pack the hollow body structure and block the flow of blood intothe hollow body structure. Advantageously, isolating the hollow bodystructure from circulation minimizes the risk of rupturing the hollowbody structure.

For example, FIGS. 22E-22F show an example of an embolic mass 2275formed from the delivered sections of endovascular instrument 1220,including the stabilizing frame 2071 and curved mass 2273. Embolic mass2275 may tightly pack the interior volume 2284 of the hollow bodystructure and block the flow of blood into the hollow body structure. Inanother example, embolic mass 2275 may induce blood clotting in theinterior volume 2284 of the hollow body structure and thereby block theflow of blood into the hollow body structure.

Consistent with disclosed embodiments, a tertiary structuralconfiguration of the first region may differ from a tertiary structuralconfiguration of the second region. As used herein, a tertiarystructural configuration may refer to a three-dimensional shaperesulting from the bending or curving of the coiled elongated member.For example, the elongated member may have a coiled or helically-woundsecondary structural configuration formed from winding a wire, or anequivalent structure, in continuous, regularly-spaced rings ofconsistent diameter or variable diameter. As an example, FIG. 20A showsthe elongated member of instrument 1220 arranged as a coil with one ormore variable coiling properties; this coiling shown in FIG. 20A is thesecondary structural configuration of instrument 1220. The coiled firstregion and second region of the elongated member may then bend in thefirst manner and second manner, respectively, into their respectivetertiary structural configurations. In some embodiments, the firstregion and/or the second region may be biased to bend into theirtertiary structural configurations due to, e.g., their shape-memory orother structural and/or material properties. Additionally, oralternatively, the first region and second region may be configured tobend further into quaternary and/or quinary structures. In someembodiments, the elongated member may include one or more additionalregions (e.g., a third region) having a tertiary structuralconfiguration that differs from the tertiary structural configurationsof one or both of the first region and second region.

The first region of the elongated member may have a tertiary structuralconfiguration that includes a sphere, a basket, a cage, a convexthree-dimensional shape, a concave three-dimensional shape, or anotherthree-dimensional shape having an interior space within which the curvedmass of the second region may be formed. For example, the first regionmay have a tertiary structural configuration of a framing coil. In someembodiments, the tertiary structural configuration of the first regionmay additionally or alternatively include the shape of the stabilizingframe; thus, the first region may assume its tertiary structuralconfiguration when the first region bends in the first manner to formthe stabilizing frame. FIG. 20B illustrates an example of a tertiarystructural configuration of first region 2070, which includes thethree-dimensional shape of stabilizing frame 2071. In some embodiments,the first region may be configured to assume a predetermined,three-dimensional structural configuration in the presence of body fluidto form the frame within the hollow body structure. As used herein, apredetermined, three-dimensional structural configuration of the firstregion may refer to the final three-dimensional shape of the firstregion within the hollow body structure; this shape may include thetertiary structural configuration or, alternatively, this shape mayinclude further bending of the first region into a predeterminedquaternary or quinary configuration. The first region of the elongatedmember may be configured to bend into its final three-dimensional shapewhen the first region is exposed to a liquid or to body fluid such asblood, urine, cerebrospinal fluid, etc. Thus, when the first region isdelivered into a hollow body structure having body fluid therein, thefirst region may be configured to bend into its predetermined,three-dimensional structural configuration to form the stabilizing framewithin the hollow body structure.

The second region of the elongated member may have a tertiary structuralconfiguration that includes a helix, a sphere, or anotherthree-dimensional shape. In some embodiments, the second region may havea tertiary structural configuration of a filling coil or of a finishingcoil. For example, FIG. 20B shows an example of a second region 2074having a first helical shape, and FIG. 21B shows another example of asecond region 2074 a having a second, different helical shape. In someembodiments, the second region may bend, either partially or completely,into its tertiary structural configuration within the stabilizing frameto form the curved mass, as discussed above. Consistent with disclosedembodiments, the second region may be configured to be delivered intothe hollow body structure after the first region and to fill space inthe three-dimensional structural configuration of the first region. Forexample, after the first region is delivered into the hollow bodystructure and bends in the first manner to form the stabilizing frame,the second region may bend in the second manner to form the curved masssubstantially within the frame, thus filling at least some of the spacewithin the frame.

Consistent with disclosed embodiments, at least one structural propertymay differ between the first region and the second region of theelongated member. As used herein, a structural property may include adesign feature of the elongated member (e.g., outer diameter,three-dimensional shape, cross-sectional shape, or axial length) and/ora material property of the elongated member (e.g., material composition,elasticity, or stiffness). Consistent with disclosed embodiments, the atleast one structural property differing between the first region andsecond region may include at least one of stiffness, flexibility,material composition, outer diameter of the first and second regions,diameter of the elongated member, three-dimensional shape,cross-sectional shape, axial length, and number of turns per unit oflength. It is due to the different structural properties that the firstregion and second region may be configured as different types ofendovascular coils (e.g., the first region may be configured as aframing coil and the second region may be configured as one of a fillingcoil or a finishing coil).

Consistent with disclosed embodiments, an outer diameter of the firstregion may be larger than an outer diameter of the second region. Forexample, the first region and the second region may have respectiveouter diameters within the range of 1 mm to 45 mm, with the differencebetween the outer diameters of the first region and second regionfalling within the range of 0%-50%. In another example, one or more ofthe outer diameters of the first and second regions may be outside therange of 1 mm to 45 mm, or the difference between the outer diametersmay be outside the range of 0%-50%.

Consistent with disclosed embodiments, the first region may be stifferthan the second region. In some non-limiting examples, the greaterstiffness of the first region may be due to the first region having asmaller coil angle than the second region, the first region having asmaller coil pitch than the second region, the first region having alarger outer diameter than the second region, the diameter of theelongated member being larger in the first region than in the secondregion, and/or the first region being constructed from a more rigidmaterial than the second region. In some embodiments, the first regionand second region may have respective spring constants within the rangeof 0.12 to 0.28 N/m, with the spring constant of the first region beingat least 10% greater than the spring constant of the second region. Inother examples, one or more of the spring constants of the first regionand second region may be outside the range of 0.12 to 0.28 N/m. In otherexamples, the spring constant of the first region may be smaller than,equal to, or less than 10% greater than the spring constant of thesecond region.

Consistent with disclosed embodiments, an axial length of the firstregion may be shorter than an axial length of the second region. In someembodiments, the first region may be configured as an entire framingcoil and may have, for example, an axial length of between 5 cm and 60cm. In another example, the axial length of the first region may lessthan 5 cm or more than 60 cm. Additionally, or alternatively, the secondregion may include the totality of all filling coils to be used in anendovascular procedure, optionally with a surplus length of coil. Insome embodiments, the second region may have an axial length of between10 cm and 500 cm. In another example, the axial length of the secondregion may be less than 10 cm or more than 500 cm. In some examples, theaxial length of the second region may be at least twice the axial lengthof the first region, at least three times the axial length of the firstregion, at least five times the axial length of the first region, or atleast ten times the axial length of the first region. In other example,the axial length of the second region may be less than twice the axiallength of the first region, less than the axial length of the firstregion, and so forth.

Consistent with disclosed embodiments, the endovascular instrument maybe constructed from one or more materials, such as Nitinol, platinum,tungsten, iridium, platinum-tungsten alloy, platinum-iridium alloy orany other suitable metal or metallic alloy. In some embodiments, theentire endovascular instrument (including the first region, secondregion, and any other regions therein) may be constructed from the samematerial. Alternatively, two or more regions of the endovascularinstrument may be constructed from different materials. For example, insome embodiments the first region may be constructed of a first alloy(e.g., platinum-tungsten alloy, platinum-iridium alloy, or any othersuitable metallic alloy) and the second region may be constructed of asecond alloy differing from the first alloy (e.g., platinum-tungstenalloy, platinum-iridium alloy, or any other suitable metallic alloy).

Consistent with disclosed embodiments, the endovascular instrument mayinclude a support mechanism configured to push the first region in adistal direction, the support mechanism being selectively detachablefrom the elongated member. As used herein, a support mechanism mayinclude a structure configured to stabilize or confine the second regionof the elongated member, such that twisting and kinking of the secondregion is reduced or prevented when a distally-directed force is appliedto the second region. For example, since the second region of theelongated member may be proximal to the first region, adistally-directed force may be applied to the second region in order topush the first region distally. As the second region may be softer andmore flexible than the first region in various embodiments, thisapplication of force may cause unintended twisting or kinking of thesecond region. By stabilizing the second region with a supportmechanism, the distally-directed force may be applied to the secondregion with reduced twisting and kinking, while also delivering theapplied force (at least in part) to the first region, thus pushing thefirst region in a distal direction.

In some embodiments, the support mechanism may include at least onedelivery wire arranged parallel to the second region. The at least onedelivery wire may be arranged to extend through an interior of theelongated member or may be arranged external to the elongated member.The at least one delivery wire may have a first end that may beconnected to the elongated member at, for example, the proximal end ofthe first region, the distal end of the second region, a connectorbetween the first region and the second region, or any other suitablepart of the elongated member. The second end of the at least onedelivery wire may be connected to a feature that is proximal to thefirst end of the delivery wire; examples of the feature may include adistal end of a shaft or handle, a proximal end of the second region ofthe elongated member, a torquer of the endovascular instrument, aconnector connecting the proximal end of the second region with anotherregion of the elongated member or with another device, or any othersuitable location. In some embodiments, the at least one delivery wiremay be configured to exert force on at least a part of the second regionof the elongated member and/or exert force on at least one end of thesecond region of the elongated member and/or exert opposing forces onthe proximal and distal ends of the second region of the elongatedmember, thus preventing the second region from twisting or buckling overitself when a pushing force is applied to the endovascular device. Thus,some or all of the applied force may be transferred to the first regionof the endovascular device, pushing the first region in a distaldirection. When desired, the at least one delivery wire may be removedfrom the portions of the endovascular device to which it may beconnected.

In alternative embodiments, the support mechanism may include a sleeveconfigured to engulf at least a portion of the second region of theelongated member. In some embodiments, the sleeve may engulf the entirelength of the second region or a portion thereof; the sleeve may engulfthe proximal end of the second region, the distal end of the secondregion, and/or a middle section of the second region. In someembodiments, the proximal end of the sleeve may be connected to amanipulable control element (e.g., a control wire, a torquer, a shaft,or a handle) so that axial movement of the sleeve and, through thesleeve, the second region of the elongated member may be controlled.Alternatively, the sleeve may extend proximally to a location of a userof the endovascular device, such that the user may directly manipulatethe sleeve.

At least a portion of the sleeve may be connected to the second regionof the elongated member by, for example, friction fit, a mechanicalengagement or connector, adhesive, or any other suitable connectionmeans. For example, the distal end of the sleeve may be connected to thesecond region. Due to the connection, a distally-directed force appliedto the sleeve may be transferred to the second region so that the sleevemay be configured to advance in the distal direction together with thesecond region. The second region may, in turn, exert the distally-forcedforce on the first region of the elongated member, pushing the firstregion in the distal direction without twisting or buckling the secondregion.

In some embodiments, the sleeve may be configured to be selectivelydetached from the elongated member through movement in a proximaldirection relative to the second region of the elongated member. Forexample, the distal end of the sleeve may engage a portion of the secondregion and may push the second region in a distal direction. However,the engagement between the sleeve and the second region of the elongatedmember may be lost when the sleeve is moved in a proximal direction,such that the elongated member may remain stationary when the sleeve ispulled proximally. By this mechanism, the sleeve may be used to push thesecond region of the elongated member and, through it, the first regionof the elongated member in the distal direction. When the elongatedmember is advanced to a desired location, the sleeve may be disengagedfrom the second region (either manually or automatically) via proximalmovement of the sleeve away from the elongated member.

In some embodiments, such as the example of endovascular device 2500depicted in FIGS. 25A and 25B, a support mechanism 2580 may include asleeve configured to engage second region 2072 of an endovascularinstrument. In this example, a distal end of the support mechanism mayabut a portion of second region 2072, such that the support mechanism2580 may be actuated to push endovascular instrument in a distaldirection (i.e., to the left in FIGS. 25A and 25B). As shown in FIG.25B, distal movement of the support mechanism 2580 and second region2072 may, in turn, cause distal movement of the first region 2070 of theelongated member until the first region is moved to a desired position.Support mechanism 2580 may then be selectively detached from theelongated member by being moved in a proximal direction, while theelongated member may remain in place.

Consistent with disclosed embodiments, the first region of the elongatedmember may be configured to be detached from the second region of theelongated member following delivery of the first region to the hollowbody structure. As a result, the first region may remain in place withinthe hollow body structure while the second region is moved relative tothe hollow body structure, such as during delivery of the second regioninto the hollow body structure or removal of the second region from thepatient's body. In embodiments in which the first region is configuredas a framing coil, detachment of the first region from the second regionmay separate the framing coil from the remainder of the elongated membersuch that the framing coil may bend to form the stabilizing frame withinthe hollow body structure.

Additionally, or alternatively, at least a first portion of the secondregion of the elongated member may be configured to be detached from asecond portion of the second region within the hollow body structureafter detachment of the first region of the elongated member from thesecond region. In some embodiments, the first portion of the secondregion may include a distal portion of the second region, and the secondportion of the second region may include a proximal portion of thesecond region. For example, after the first region of the elongatedmember is detached from the second region, the second region may be thedistal-most region of the elongated member. When it is desired todeliver a first portion (e.g., a distal portion) of the second regioninto the hollow body structure without delivering a second portion(e.g., a proximal portion) of the second region, the first portion maybe separated from the second portion so that the first portion mayremain in place within the hollow body structure while the secondportion is moved relative to the hollow body structure (e.g.,subsequently delivered to the hollow body structure) or else removedfrom the patient's body. Advantageously, in situations in which only afraction of the second region is needed for delivery to the hollow bodystructure, this configuration may allow a desired length of the secondregion to be delivered to the hollow body structure without requiringthe entire second region to be delivered, which might result inover-packing the hollow body structure.

In some embodiments, the first region of the elongated member may bedetached from the second region of the elongated member by a coildetachment mechanism (discussed in detail below). Similarly, the firstportion (e.g., distal portion) of the second region may be detached fromthe second portion (e.g., proximal portion) of the second region by acoil detachment mechanism. Additionally, or alternatively, apartitioning mechanism may be provided to detach the first region of theelongated member from the second region of the elongated member and/orto detach the first portion (e.g., distal portion) of the second regionfrom the second portion (e.g., proximal portion) of the second region.For example, the partitioning mechanism may be connected to anendovascular device used to deliver the endovascular instrument to thehollow body structure. Once the first region of the elongated member hasbeen advanced to a desired position (e.g., advanced out of theendovascular device into the hollow body structure), the partitioningmechanism may be activated to sever (i.e., completely detach orseparate) the first region of the elongated member from the secondregion. Advantageously, the partitioning mechanism may allow the firstregion to be detached from the second region even if a coil detachmentmechanism is not provided in between the first and second regions.Additionally, or alternatively, once a desired length of the secondregion is advanced from the endovascular device into the hollow bodystructure, the partitioning mechanism may be activated to sever thefirst portion (e.g., distal portion) of the second region from the restof the elongated member. Advantageously, the partitioning mechanism mayallow a desired length of the second region to be delivered to thehollow body structure without requiring the entire second region to bedelivered, which might result in over-packing the hollow body structure.

Consistent with disclosed embodiments, the endovascular instrument mayinclude at least one coil detachment mechanism configured to sever theelongated member while the elongated member is within a patient's body.As used herein, a coil detachment mechanism may include a featureprovided on the endovascular instrument that is configured to detachablyconnect two sections of the elongated member together or to detachablyconnect the elongated member to another structure such as a deliverywire or support mechanism (e.g., shaft). The coil detachment mechanismmay be activated (e.g., by a user) to detach (i.e., remove theconnection between) the two features being connected by the coildetachment mechanism. Some non-limiting examples of a coil detachmentmechanism may include electrolytic detachment features, mechanicaldetachment features (e.g., screw connectors, male-female connectors, orremovable latch or pin connectors), degradable adhesive (e.g.,degradable polymer adhesive), connections detached by heat application,and connections detached by application of electric current. Consistentwith disclosed embodiments, the coil detachment mechanism may beconfigured to sever the elongated member in at least one of a firstdetachment location between the first region and the second region, asecond detachment location between the second region and a deliverywire, or a third detachment location along a length of the secondregion. In some embodiments, only one of the detachment locationsincludes a coil detachment mechanism. Alternatively, multiple or all ofthe detachment locations may include a coil detachment mechanism. One ormore coil detachment mechanisms may additionally be provided at otherportions of the elongated member or at the location of a connectionbetween the elongated member and another structure (e.g., a deliverywire or sheath, or a support mechanism).

Consistent with disclosed embodiments, the second region of theelongated member may be configured to connect to a delivery wire. Asused herein, a delivery wire may include a wire, fiber, sheath, or otherstructure configured to connect to the second region of the elongatedmember so as to control movement of the elongated member relative to adelivery device and/or relative to the body of the patient. In someembodiments, the distal end of the delivery wire may have a removableconnection to the second region of the elongated member, such as a screwconnector, male-female connector, or removable latch or pin connector.The proximal end of the delivery wire may be connected to a manipulablecontrol element (e.g., a control wire, a torquer, a shaft, or a handle)or, alternatively, may be directed manipulated by a user. The deliverywire may be moved distally, proximally, or rotationally to cause acorresponding movement of the elongated member; under control of thedelivery wire, the elongated member may be advanced to a desiredlocation within the body of the patient and arranged in a desiredconfiguration at the location. The delivery wire may then be detachedfrom the elongated member and removed, while the elongated member mayremain in a delivery location. Additionally, or alternatively, anotherregion of the elongated member may be configured to connect to adelivery wire, such as any region of the elongated member locatedproximal to the second region.

Consistent with disclosed embodiments, the elongated member may includeat least one imaging marker. As used herein, an imaging marker mayinclude a feature or material on or within the elongated member that isconfigured to be visualized or detached from outside the patient's bodyso that the location of the marker, and thus the location of theelongated member, may be determined. Some non-limiting examples ofimaging markers may include radiopaque markers (e.g., gold, platinum,tantalum, or tungsten), ultrasound-visible markers (e.g., glass orceramic microballoons or microspheres), magnetic resonance markers(e.g., gadolinium foil and powder, gadolinium salts, nanocrystallineiron oxide, or iron powder), or any other fiducial markers configured tobe detected under one or more imaging modalities. The at least oneimaging marker may be configured on the elongated member as a band,strip, paddle, dot, or any other shape or configuration.

In some embodiments, at least one imaging marker may be included on theelongated member in a first marker location between the first region ofthe elongated member and the second region of the elongated member.Additionally, or alternatively, at least one imaging marker may beincluded on the elongated member in a second marker location between thesecond region of the elongated member and a delivery wire. Additionally,or alternatively, at least one imaging marker may be included on theelongated member in a third marker location at a distal tip of the firstregion of the elongated member. Additionally, or alternatively, at leastone imaging marker may be included on the elongated member in a fourthmarker location at a proximal end of the second region of the elongatedmember. Advantageously, the at least one imaging marker may allow theelongated member to be visualized as it is moved within the patient'sbody, e.g., by the support mechanism or a delivery wire.

Aspects of the present disclosure may relate to a novel device for thedelivery of endovascular instruments, including but not limited toendovascular coils, to a treatment site within a body, including but notlimited to aneurysms and other hollow body organs. The novel device mayfurther include a flexible, elongated sheath, which may be, for example,a hollow delivery catheter or microcatheter. Further, in someembodiments, an electrode may be configured on an inner surface of theflexible, elongated sheath near the distal tip of the flexible,elongated sheath. Consistent with disclosed embodiments, an electrodemay be configured to deliver electric current to an endovascularinstrument, which may be, for example, an endovascular coil. Theendovascular instrument may be axially advanced through the flexible,elongated sheath, resulting in the cutting or severing of the portion ofthe endovascular instrument that may be in contact with the electrode.Thus, in such embodiments, the severed section of the endovascularinstrument may remain within an aneurysm while the rest of theendovascular instrument may be removed from the body with the flexible,endovascular sheath, or may be used for further filling of the aneurysm.

In some embodiments of the present disclosure, a novel device may beconfigured with an electrode on an inner surface of a microcatheter.Microcatheters, and other types of flexible, elongated sheaths,incorporating electrodes may be used for ablation procedures, whereaselectrodes on the outer surface of a microcatheter, and other types offlexible, elongated sheaths, may selectively destroy tissue. The noveldevice may have electrodes mounted only on the inner surface fordelivery of current through the inner lumen. Thus, current may not flowto the surrounding tissue and may not injure the patient.Advantageously, this may allow the coil-cutting mechanism to be usedwhile the microcatheter, or other type of flexible, elongated sheath,may be within the patient's body, without risk of accidental damage tohealthy tissue.

Aspects of the present disclosure may relate to medical devicesconfigured for the delivery of an endovascular instrument to a treatmentsite within a body. As used herein, a medical device may include anyapparatus, device or instrument configured to be delivered into, or tootherwise come in contact with, the body of a patient for use in thediagnosis of a disease or condition, in the cure, mitigation, treatment,or prevention of disease, to perform a medical operation or procedure,or any other suitable medical purpose. Some non-limiting examples of themedical device may include catheters, microcatheters, trocars, cannulae,needles, or any other hollow medical tubing or device configured to beinserted or delivered into a patient's body.

Consistent with disclosed embodiments, the exemplary medical device maybe configured for delivery of an endovascular instrument to a treatmentsite within a body. As used herein, delivery of the endovascularinstrument to a treatment site may include using the medical device forconveying, carrying, transporting, distributing, or any other similarmeans of facilitating movement of the endovascular instrument from anorigin site (e.g., outside of the patient's body) to an area of apatient's body intended to receive medical treatment, optionally fromthe medical device. In some embodiments, the treatment site may includea hollow body structure such as an aneurysm, as discussed herein. Insome embodiments, the medical device may be advanced through the body(e.g., over a guidewire) until the distal end of the medical device islocated at or in close proximity to the treatment site. Then, themedical device may be used to pass the endovascular instrument fromoutside the patient's body to the treatment site. In some embodiments,the endovascular instrument may be passed through an inner lumen of themedical device to reach the treatment site. Additionally, oralternatively, the endovascular instrument may be delivered over themedical device to reach the treatment site.

FIGS. 12A and 12B depict an exemplary medical device 1200, which mayinclude an elongated sheath 1210 (e.g., a microcatheter). As shown inFIGS. 12A and 12B, the medical device 1200 may be configured to deliveran endovascular instrument 1220, such as an endovascular coil. As shownin FIG. 22A, the endovascular coil 1250 may be delivered to a hollowbody structure 2282, such as an aneurysm. For example, endovascularinstrument 1220 may be delivered through inner lumen 1214 of medicaldevice 1200 to the hollow body structure 2282, for example topermanently implant at least part of the endovascular instrument 1220within the hollow body structure 2282. As shown in FIGS. 22E-22F,medical device 1200 may then be removed from the body, and in someexamples may leave at least part of endovascular instrument 1220implanted within the hollow body structure 2282.

Consistent with disclosed embodiments, the medical device may include aflexible, elongated sheath having a proximal end and a distal end. Asused herein, the term “proximal” may refer to a location closer to theuser or operator of the sheath (e.g., a physician). The term “distal”may refer to a location closer to the treatment location, as discussedherein.

FIGS. 12A and 12B depict an example of a medical device 1200, which mayinclude a flexible, elongated sheath 1210. For example, sheath 1210 mayinclude a catheter, a microcatheter, or any other suitable sheath. Thesheath 1210 may have a distal end 1212 and a proximal end (not shown).

Consistent with disclosed embodiments, the medical device may include aninner wall of the flexible, elongated sheath delimiting an inner lumenextending between the proximal end and the distal end of the flexible,elongated sheath. Embodiments may include a distal section of theflexible, elongated sheath that terminates at the distal end of theflexible, elongated sheath. Some embodiments of the medical device maybe configured such that a distal section of the flexible, elongatedsheath has an axial length of one inch or less, ten inches or less, onecentimeter or less, two millimeters or less, or any other similarmeasurement. As used herein, axial length may refer to the length of thedistal section of the flexible, elongated sheath measured in relation toor around a real or imaginary line (such as a straight line, a curvedline, etc.) going through the center of the endovascular instrument. Asused herein, the inner lumen may include an interior passage or insidespace of a tubular or hollow structure. As discussed herein, delimitingmay refer to determining, establishing, setting, fixing, defining,delineating or any other means of determining the limits or boundariesof the inner lumen. Advantageously, an inner wall of the flexible,elongated sheath may form the inner lumen within the flexible, elongatedsheath that may extend between the proximal end and the distal end ofthe flexible, elongated sheath. Additionally, or alternatively, theinner lumen formed by the inner wall of the flexible, elongated sheathmay provide space for an endovascular instrument to pass through to thetreatment site. In alternative embodiments, one, two, three or multipleinner walls of the flexible, elongated sheath may form one, two, threeor many inner lumens within the flexible, elongated sheath that mayextend between the proximal end and the distal end of the flexible,elongated sheath.

FIGS. 12A and 12B depict an exemplary medical device 1200 which mayinclude an outer tube 1230 with an inner wall 1211 of the flexible,elongated sheath 1210. The inner wall 1211 may form an inner lumen 1214extending between a proximal end and a distal end of the flexible,elongated sheath. As depicted in FIGS. 12A and 12B, the flexible,elongated sheath 1210 may be a microcatheter. In some embodiments, anendovascular instrument 1220 may be advanced through the inner lumen1214 to the treatment site. FIGS. 12A and 12B also illustrate a distalsection of the flexible, elongated sheath 1210, not necessarily drawn toscale, configured to any axial length including but not limited to oneinch or less, ten inches or less, one centimeter or less, twomillimeters or less or any other similar measurement.

Consistent with disclosed embodiments, the medical device's inner lumenmay be sized to enable axial advancement of the endovascular instrumenttherethrough. As used herein, axial advancement may be the forward,onward or backward movement relating to or around a real or imaginaryline (such as a straight line, a curved line, etc.) going through thecenter of the endovascular instrument. A non-limiting example of aninner wall size of a flexible, elongated sheath may include an innerlumen with a larger diameter than an outer diameter of the flexible,elongated sheath. Another non-limiting example of the inner wall size ofthe flexible, elongated sheath may include a stretchable sheath thatenables an endovascular instrument to axially advance through, where aperimeter of a cross section of the inner lumen of the flexible,elongated sheath stretches during axial advancement of the endovascularinstrument. For example, the medical device may have a diameter smallerthan the diameter of the inner lumen of the flexible, elongated sheathso that the endovascular instrument (for example, an endovascular coil)may axially advance to the treatment site. Additionally, oralternatively, the flexible, elongated sheath may not have the innerlumen with a larger diameter than the outer diameter of the endovascularinstrument. Thus, when the endovascular instrument axially advancesthrough the inner lumen or multiple inner lumens, the flexible,elongated sheath may stretch to allow the endovascular instrument toreach the treatment site.

FIG. 16A depicts an example of a medical device 1200 axially advancingtowards the treatment site. FIGS. 16B-16C illustrate a cross sectionalview of the example of the medical device 1200 depicted in FIG. 16A.FIG. 16B provides a depiction of an inner lumen 1214 having a smallerdiameter 1668 than an outer diameter 1666 of a flexible, elongatedsheath 1210 for axial advancement of an endovascular instrument 1220(e.g., an endovascular coil) to reach the treatment site.

Consistent with disclosed embodiments, the medical device may include atleast one electrode within the distal section of the flexible, elongatedsheath. As used herein, at least one electrode refers to an electricalconductor used to selectively make contact with an object and to enablean electrical current to flow from the at least one electrode to theobject or from the object to the at least one electrode. The at leastone electrode may be made of, for example, copper, zinc, gold, platinum,titanium, brass, graphite or any other suitable material, includingcombinations of the same. Other non-limiting examples of such objectsmay include an endovascular instrument, an endovascular coil, and soforth. In some embodiments, the at least one electrode may permanentlyor selectively make contact with an object by connecting the at leastone electrode to a wire made of electrical conductor material, and thecurrent may flow from the wire to the object through the at least oneelectrode or from the object to the wire through the at least oneelectrode. In some examples, selectively making contact with the objectmay include making contact with the object when particular conditionsare fulfilled and not making contact with the object when the particularconditions are not fulfilled. For example, the at least one electrodemay be configured to selectively make contact with a segment of theendovascular instrument within an inner lumen. In some examples, theparticular conditions may include any combination of: (i) the segment ofthe endovascular instrument being within a particular region of theinner lumen, (ii) the segment of the endovascular instrument having adiameter of at least a selected threshold, and (iii) the at least oneelectrode being in a position (of a plurality of alternative possiblepositions of the electrode) that fulfills a condition. In some examples,one or more of the above conditions may be controlled by a user, by anautomated process, and so forth.

FIGS. 12A and 12B depict an example of a medical device 1200 with atleast one electrode 1242 within the distal section 1213 a of the sheath.In FIG. 14, the at least one electrode 1242 may be connected via anembedded wire 1243 (e.g., copper wires) to the distal end 1213 a of aflexible, elongated sheath and to the controller and power source. FIG.16A depicts the at least one electrode 1242 selectively not in contactwith an object (e.g., an endovascular instrument 1220). FIG. 17A depictsa section of the endovascular instrument 1220 selectively in contactwith the at least one electrode 1242, 1244.

Consistent with disclosed embodiments, at least one electrode may beconfigured to selectively deliver an electric current through a segmentof the endovascular instrument within the inner lumen. As used herein,an electric current may be any movement or stream of electric chargecarriers including electrons, protons, ions or any other electricallycharged particle through an electrical conduct or space. As discussedherein, the electric current may be delivered selectively,restrictively, individually, personally, particularly, specifically orin any other way that involves the selection of a parameter. In someexamples, the at least one electrode may be configured to selectivelydeliver the electric current through the segment of an endovascularinstrument within an inner lumen, for example to deliver the electricalcurrent when particular conditions are fulfilled. In some examples, theparticular conditions may include any combination of: (i) the at leastone electrode may be making contact with a segment of an endovascularinstrument within the inner lumen (which may be controlled as describedabove), or with another particular part of the endovascular instrument;and (ii) there may be an electric potential difference between the atleast one electrode and a segment of the endovascular instrument, orbetween the at least one electrode and a second electrode making contactwith a segment or other particular part of the endovascular instrument.The electric potential difference may be controlled, for example byconnecting or disconnecting the at least one electrode to an electricpower source, for example using the wire described above, for example bya user, by an automated process, and so forth.

FIGS. 12A and 12B illustrate an exemplary medical device with at leastone electrode 1242 configured to selectively deliver an electric currentthrough a segment of an endovascular instrument 1220 (e.g., anendovascular coil) within an inner lumen 1214 of a flexible, elongatedsheath 1210 (e.g., a microcatheter). FIG. 18A depicts a severed coilsection 1826 with a severed coil end 1826 a and a remaining coil section1828 after the at least one electrode 1242 selectively delivers theelectric current through the segment of the endovascular instrument 1220(e.g., the endovascular coil).

Consistent with disclosed embodiments, an electric current may bedelivered selectively through the segment of the endovascular instrumentwhile the distal section of the sheath may be positioned within thebody. The distal section of an elongated, flexible sheath may bepositioned, deposed, deposited, disposed, emplaced, fixed, laid, placed,put, set, set up, situated or arranged in any other way within the body.For example, the distal section the elongated, flexible sheath may beadvantageously axially advanced to a treatment site within a patient'sbody to a hollow body structure, such as an aneurysm. Upon arrival ofthe distal section, the electric current may be delivered selectivelythrough an endovascular instrument.

FIGS. 12A and 12B illustrate an exemplary medical device 1200 fordelivery to a treatment site, such as an aneurysm 2282 within a body.The medical device 1200 may include a flexible, elongated sheath 1210having a proximal end and a distal end. The flexible, elongated sheath1210 (e.g., a microcatheter) may have a distal end 1212 to be axiallyadvanced to a hollow body structure 2282 (e.g., an aneurysm). Once thedistal end of the flexible, elongated sheath 1212 has reached theaneurysm, an electric current may be delivered selectively through thesegment of an endovascular instrument 1220 (e.g., an endovascular coil).

Consistent with disclosed embodiments, the at least one electrode may beconfigured to sever a portion of the endovascular instrument in contactwith the at least one electrode, such that a region of the endovascularinstrument distal to the severed portion may be detached from a secondregion of the endovascular instrument. An endovascular instrument may bein contact with the at least one electrode when a union or junction ofsurfaces or any other method of meeting occurs. As discussed herein,sever may refer to disconnecting, separating, splitting, cutting,slicing, or any other means to partition the endovascular instrumentinto two or more individual pieces, which are distinct from and can bemoved relative to the other parts of the endovascular instrument. Forexample, the endovascular instrument can make contact with the at leastone electrode in a plethora of ways including, but not limited to, (i)on an inner wall of an inner lumen across from a constrictor (forexample, across from a balloon), (ii) on the inner wall of the innerlumen next to a constrictor (for example, next to a balloon), (iii) on aconstrictor (for example, on a balloon), or (iv) on no inner wall of theinner lumen but within the inner lumen.

FIG. 18A illustrates an exemplary medical device 1200 with at least oneelectrode 1242. FIG. 17A depicts a coil section 1724 in contact with theat least one electrode 1242, 1244. Some embodiments, including but notlimited to FIG. 18A, may depict a severed coil section 1826, a severedcoil end 1826 a, and a remaining coil section 1828. As shown in FIG.18B, the severed coil section 1826 may be detached from the remainingcoil section 1828. Advantageously, FIG. 16A depicts the at least oneelectrode 1242 on an inner wall of an inner lumen 1214 across from aballoon 1260.

Consistent with disclosed embodiments, the at least one electrode mayinclude at least one conductive filament connected to the inner wall ofthe distal section of the sheath. As used herein, the at least oneconductive filament may be positioned in an internal part of a distalportion of a flexible, elongated sheath. As used herein, the at leastone conductive filament may be one where electricity can flow through afilament. As used herein, connected may include filaments mounteddirectly to, attached directly to, attached indirectly to an inner wallof a distal section of a flexible, elongated sheath via a third objector any other similar means. Some non-limiting examples of at least oneconductive filament may include copper, silicon, rubber, elastic or anyother property so that the at least one conductive filament, twoconductive filaments, or multiple conductive filaments may be pushedaway towards the inner wall of an elongated, flexible sheath by anendovascular instrument passing through an inner lumen which may createcontact with the endovascular instrument without blocking it.Advantageously, the at least one conductive filament may be configuredto wrap helically around the inner wall of the distal section of theflexible, elongated sheath. In other embodiments, the at least oneconductive filament may also be configured to line the inner wall of thedistal section of the flexible, elongated sheath. Alternatively, oradditionally, one conductive filament may wrap helically around theinner wall of the distal section of the flexible, elongated sheath andanother or multiple other conductive filaments may wrap helically bycrossing the one conductive filament.

FIG. 3 illustrates an exemplary system 300 for endovascular coilcutting. At the flexible, elongated sheath distal end 112, coil-cuttingapparatus 340 may include electrodes 342, 344 that may bulge into theflexible, elongated sheath's lumen 114 from opposite sides to formpassive elements 347, 348 configured, for example, as leaf springs.Passive elements 347, 348 may be biased toward the center of theflexible, elongated sheath 110, such that electrodes 342, 344 may remainin contact with coil 120 even while the coil is moved distally orproximally. When an electrical current pulse is received from the powersource and delivered to electrodes 342, 344 via wires 343, 345,respectively, passive elements 347, 348 may pass the current throughcoil section 124 to sever the coil. As a result, the distal segment 122of the coil may be detached from the flexible, elongated sheath 110 andfrom the remainder of the coil 120.

Consistent with disclosed embodiments, the at least one electrode may bea first electrode in a pair of spaced-apart electrodes. In someembodiments, the at least one electrode may be a second or any otherelectrode in the pair or pairs of spaced-apart electrodes. As usedherein, a pair of spaced-apart electrodes may be arranged with space orspaces between two or more electrodes. Non-limiting examples of the pairof spaced-apart electrodes may include two or more electrodes proximallyor distally situated to the balloon, on a surface of the balloon at theextremum point, proximal to the extremum point, distal to the extremumpoint, left of the extremum point, right of the extremum point or anyother similarly situated relation of space. Other non-limiting examplesof the pair of spaced-apart electrodes may include two or moreelectrodes proximally or distally situated to a constrictor, on asurface of the constrictor at the extremum point, proximal to theextremum point, distal to the extremum point, left of the extremumpoint, right of the extremum point or any other similarly situatedrelation of space. More examples of the pair of spaced-apart electrodesmay further include situating two or more electrodes on a flexible,elongated sheath to either side of the constrictor or the balloon, onthe opposite side of the flexible, elongated sheath from the constrictoror the balloon or on any other side of a wall of an inner lumen.

FIGS. 12A and 12B illustrate an example of a medical device 1200 with atleast one electrode 1242. FIGS. 12A and 12B depict a sealing distal tip1232 at a distal end of the endovascular device 1202. In someembodiments, sealing distal tip 1232 may be made of a conductivematerial, and thus, sealing distal tip 1232 may be or include the atleast one electrode 1242. In such embodiments, sealing distal tip 1232may be a second electrode. In FIG. 12B, a balloon 1260 may be depictedacross from the at least one electrode 1242. FIG. 13 illustrates anembedded wire 1345 within an outer tube 1230 of a flexible, elongatedsheath 1210 (e.g., a microcatheter) which runs to a distal end of theouter sheath to the sealing distal tip 1232. Advantageously, inembodiments in which sealing distal tip 1232 is made of conductivematerial, FIGS. 12A and 12B depict the at least one electrode 1242 inrelation to the second electrode within the sealing distal tip 1232which forms one non-limiting example of a pair of spaced-apartelectrodes.

Consistent with disclosed embodiments, the first electrode and thesecond electrode may be situated at different longitudinal positionsalong the medical device. As used herein, different longitudinalposition may relate to a space or spaces relative to the instrument'slength rather than width. Some non-limiting examples may include thefirst and second electrode or more electrodes spaced one inch or less,ten inches or less, one centimeter or less, two millimeters or less orany other similar measurement measured in relation to the length of themedical device.

FIGS. 12A and 12B illustrate an example of a medical device 1200 withthe at least one electrode 1242 in a pair of spaced-apart electrodes. Insome embodiments, as discussed above, FIGS. 12A and 12B also depict asecond electrode within at the distal end of an endovascular device 1202at a sealing distal tip 1232. Further, FIGS. 12A and 12B depict the atleast one electrode 1242 and the second electrode within the distal endof the endovascular device 1202 at the sealing distal tip 1232 atdifferent longitudinal positions.

Further consistent with disclosed embodiments, the pair of electrodesmay be configured to cause electric current to flow along a path fromthe first electrode to a second electrode of the pair of electrodes andbe configured to sever the endovascular instrument along the path. Asused herein, flow may refer to the stream or movement of electriccurrent. As used herein, path may refer to a line, pathway, route or anyother direction between two points. A non-limiting example of electriccurrent flowing along a path may include taking a wire and connectingthe positive and negative terminals on a battery together. The electriccurrent may flow along any path between two or more electrodes includingbut not limited to: (i) through an inner lumen, (ii) through a flexible,elongated sheath, (iii) around a flexible, elongated sheath and thenthrough the sheath or any other path formed between two or moreelectrodes. Further consistent with disclosed embodiments, the path fromthe first electrode to the second electrode passes through the innerlumen of the flexible, elongated sheath. As used herein, passing throughmay refer to moving, transferring, traveling or going through someplace, thing, or space on the way to some other place, thing, or space.A non-limiting example may include electrical current passing through ametal, aqueous solution, graphite or any other substance in which anelectrical charge can flow.

FIGS. 12A and 12B illustrate an example of a medical device 1200 with anembedded wire 1243 within a flexible, elongated sheath 1210. FIG. 16Cdepicts, solely for illustrative purposes, a cross sectional view of theexample of a medical device 1200 and the embedded wire 1243 within theinner lumen 1214 of the flexible, elongated sheath 1210. FIG. 18Aillustrates the aftermath of an electric current flowing along a pathfrom the at least one electrode 1242 to the second electrode locatedwithin the sealing distal tip 1232. FIG. 17A illustrates the coilsection 1724 in contact with the at least one electrode 1242, 1244,resulting in a severed coil section 1826 and a remaining coil section1828.

Consistent with disclosed embodiments, the medical device may include anouter tube covering and fixedly connected to at least the distal sectionof the flexible, elongated sheath. As used herein, an outer tubecovering may enclose the medical device. A non-limiting example of theouter tube covering may be a hydrophilic or any other covering with anaffinity for water. The outer tube covering may further include thesecond electrode. As used herein, include may refer to the outer tubecovering configured to comprise, contain, embed or any other similarmean to make the second electrode part of the whole outer tube covering.As used herein, fixedly connected may relate to holding the outer tubefirmly in position, stationary, established, not subject to change orvariation, unchanging or any other means of fastened connection to theat least distal section of the sheath. Further, embodiments may befixedly connected by mounting the outer tube directly to, attacheddirectly to, attached indirectly to medical device via a third object orany other similar means.

FIGS. 12A and 12B illustrate an exemplary medical device 1200 with anouter tube covering 1230 (e.g., an outer sheath). Further, FIGS. 12A and12B may depict the outer tube 1230 to be configured with a sealingdistal tip 1232 embedded therein. In some embodiments, as discussedabove, sealing distal tip 1232 may include a second electrode.

Consistent with disclosed embodiments, the second electrode may besituated on an inner surface of the outer tube at a position distal tothe first electrode. As used herein, the outer tube covering may have aninner surface and an outer surface. As used herein, situated may referto the location, site, position, or any other certain place. Embodimentsmay be configured where the second electrode may be situated on theinner surface of the outer tube covering distally positioned to thefirst electrode. For example, the second electrode may be situatedwithin the distal end of the endovascular device next to the at leastone electrode. Another non-limiting example might be configured wherethe second electrode may be situated nearer the distal end of theendovascular device further away from the at least one electrode.

Consistent with disclosed embodiments, the at least one electrode may bepositioned on the inner wall of the sheath and may be configured tocontact the segment of the endovascular instrument to cause the electriccurrent to flow through the endovascular instrument. Some non-limitingexamples of the at least one electrode may be positioned on the innerwall of the sheath opposite a balloon, on the inner wall of the sheathnext to a balloon, on the inner wall of the distal portion, on the innerwall of the proximal portion or any other space along the inner wall ofthe sheath. Further, the at least one electrode on the inner wall of thesheath at any space may be configured to contact a segment of anendovascular instrument.

FIGS. 12A and 12B illustrate an exemplary medical device 1200 with theat least one electrode 1242 positioned on the inner wall 1211 of theflexible, elongated sheath 1210. FIGS. 12A and 12B also illustrate anendovascular instrument 1220 (e.g., an endovascular coil). FIG. 17Adepicts a coil section 1724 in contact with the at least one electrode1242, 1244.

Consistent with disclosed embodiments, the medical device may include anelectrode position element configured for selectively moving the atleast one electrode relative to the segment of the endovascularinstrument. As used herein, electrode position element may refer to thepart of the medical device where the at least one electrode sits.Consistent with disclosed embodiments, the electrode position elementmay include a portion adjacent to a side wall of the flexible, elongatedsheath and may have a flexibility greater than a flexibility of the sidewall of the flexible, elongated sheath. As used herein, portion mayrefer to a part, piece, bit, section, segment, fragment or any othersimilar part of a whole. As used herein, adjacent may refer toadjoining, abutting, close to, near to, by, by the side of, beside,alongside or any other relation relating to next to. As used herein,side wall may refer to a wall of the sheath forming a side of thesheath. As used herein, flexibility may refer to elasticity, stretch orany other descriptor relating to the quality of bending easily withoutbreaking. In some embodiments, the at least one electrode may sit withinthe distal end of the endovascular instrument. Additionally, oralternatively the at least one electrode may sit within the proximal endof the endovascular instrument. Some non-limiting examples may beconfigured where the at least one electrode sits on the same or oppositeside of the inner lumen from a balloon or balloons, sits in proximalrelation to a balloon or balloons, sits in distal relation to a balloonor balloons, sits on the apex of a balloon or balloons, sits on the sideof a balloon or balloons, sits on the end of a balloon or balloons oranother similar configuration relative to the segment of theendovascular instrument. Further, the electrode position element mayalso be configured to include a constrictor and/or balloon, as discussedherein.

FIGS. 12A and 12B illustrate an example of a medical device with anelectrode position element 1242 and a balloon 1260. FIGS. 12A and 12Bdepict at least one electrode 1242 in the distal end of an endovascularinstrument 1220 (e.g., an endovascular coil). FIGS. 16A-17C may depictthe balloon 1260 selectively moving the at least one electrode 1242relative to a segment of the endovascular instrument 1220. As depictedin FIG. 16A, in some embodiments the endovascular instrument 1220 may bewithin the inner lumen 1214 with some space between the balloon 1260 andthe at least one electrode 1242. As depicted in FIG. 17A, in someembodiments part of the balloon remains fixed to an outer surface of aflexible, elongated sheath 1210 (e.g., a microcatheter). A portion ofthe balloon may protrude into the flexible, elongated sheath 1210, sothat a section 1724 of the endovascular instrument 1220 comes intocontact with the at least one electrode 1242, 1244. In some embodiments,the balloon 1260 may have a flexibility greater than the flexibility theflexibility of the side wall of the flexible, elongated sheath 1210 asindicated by the portion 1562 of the balloon protruding into theflexible, elongated sheath.

Consistent with disclosed embodiments, the electrode position elementmay be configured to reduce a distance between the at least oneelectrode and the endovascular instrument through flexing of theelectrode position element. As used herein, reduce may refer tolessening, lowering, bringing down, decreasing, diminishing, shrinking,narrowing, contracting, shortening or any other term denoting to makesmaller or less in amount, degree, or size. As used herein, between mayrefer to the space in the middle of the at least one electrode and theendovascular instrument. As used herein, flex may refer to contracting,extending, tensing or any other reference of binding or becoming bent.For example, one or more balloons may be configured to reduce a distancebetween the at least one electrode and an endovascular instrumentthrough flexing of the electrode position element. This may beaccomplished by the electrode position element configured on the apex ofone or more balloons so that when biological material flows through aninflation passage and into one or more balloons they fill or flex toreduce the distance between the at least one electrode and theendovascular instrument.

FIG. 17A illustrates an example of a medical device 1200 with a portion1562 of a balloon 1260 protruding into a flexible, elongated sheath 1210(e.g., a microcatheter). FIG. 17B depicts a reduced distance between atleast one electrode 1242 and an endovascular instrument 1220 (e.g., anendovascular coil). The balloon 1260 may flex due to blood or otherbiological material passing through the inflation passage 1662 into andfilling the balloon 1260. This may push the balloon 1260 into theflexible, elongated sheath 1210.

Consistent with disclosed embodiments, the electrode position elementmay include a shape-memory component associated with the distal sectionof the flexible, elongated sheath. The shape-memory component, in someembodiments, may be configured to be selectively deformable for pressingthe at least one electrode against the endovascular instrument. As usedherein, deformable may refer to contorting, twisting, warping,disfiguring, misshaping or any other term relating to changing the formof a shape-memory component. As used herein, pressing may refer tobearing down on, leaning on, forcing on, squeezing on or any other termrelating to moving or causing movement into a position of contact withsomething by exerting continuous physical force. As used herein, ashape-memory component may be configured to be an alloy that can bedeformed with applying various temperature or temperatures but can alsoreturn to its pre-deformed or remembered shape when applying varioustemperature or temperatures. For example, the alloy can be Nitinol. Insome embodiments, a shape-memory component may be curved or arc-shapedso as to form a convex shape relative to the inner lumen. Any alloywhich makes a shape-memory component exhibits two distinct phases: themartensite phase at lower temperatures, in which the alloy may be easilytwisted or deformed, and the austenite phase at higher temperatures, inwhich the alloy returns to a pre-formed or “remembered” shape andbecomes stiffer and more resistant to deformation.

FIG. 7A illustrates a cylindrical base 750 and spring beam 760, eitheror both of which may be constructed from a shape-memory alloy such asNitinol. In a similar manner, some embodiments of the example of amedical device 1200 depicted in FIGS. 12A and 12B may be configured touse a shape-memory alloy. The balloon 1260 may be configured to be madeof a shape-memory component within the distal section 1212 of aflexible, elongated sheath 1210 (e.g., the microcatheter). Theshape-memory component of the balloon 1260 may be configured to beselectively deformable so as to press the at least one electrode 1214against the endovascular instrument 1220 (e.g., the endovascular coil).

Consistent with disclosed embodiments, the medical device may include atleast one controller. The at least one controller is described ingreater detail within the introduction. The controller, in someembodiments, may be configured to obtain an input and control the flowof the electric current from the at least one electrode through thesegment of the endovascular instrument based on the input. Some examplesof such input are discussed below. As used herein, input may refer towhat may be put in, taken in, or operated on by any process or systemfor example. As used herein, control may refer to running, managing,directing, administering, guiding, or determining the behavior of orsupervising the running of the flow of electric current from the atleast one electrode through the segment of the endovascular instrumentbased on the input. For example, a use may use a keyboard, joystick, ormouse as the at least one controller. Advantageously, the medical devicemay be configured to obtain an input such as the press of a button,click of a joystick, or click of a mouse to control the flow of theelectric current from the at least one electrode through the segment ofthe endovascular instrument based on the input.

FIG. 19 illustrates an exemplary medical non-transitory computerreadable medium for the medical device with instructions configured tocause a flow of electric current. FIG. 37 illustrates at least onecontroller 3700. In some embodiments, the at least one controller 3700may be configured to obtain an input 3702 and control the flow ofelectric current 3704 within the electrode control component output 1940to the endovascular device advancing mechanism component 1944.

Consistent with disclosed embodiments, the input may be configured toinclude at least one but not limited to one of: (i) an input from a userof the medical device, (ii) first data derived from at least one sensoroutput, or (iii) second data derived from at least one medical image.The flow of electric current from the at least one electrode through thesegment of an endovascular instrument may be controlled based on aninput. In one example, the input from a user may be indicative of adesire of the user to initiate, stop or adjust the flow of the electriccurrent. In some examples, the input may include an input from a user ofthe medical device, such as a press of a button, a turn of a dial, aninput through a user interface, a voice command recognized in a capturedaudio data through voice recognition algorithms, a gesture recognized ina captured image data through gesture recognition algorithms, and soforth. In some examples, the input may include data derived from atleast one sensor output. For example, the sensor may measure electricalimpedance, for example using the electrode. In some examples, the inputmay include data derived from at least one medical image, such as anx-ray image or a CT image of the medical device inside the body of thepatient. In one example, the data derived from at least one sensoroutput or the data derived from at least one medical image may beanalyzed using a classification model to determine a desired effect onthe flow of the electric current.

FIG. 19 illustrates an exemplary non-transitory computer readablemedium. In some embodiments, FIG. 19 depicts different inputs (a userinput device 1910, sensors 1912, and an imaging device 1914). FIG. 37depicts the input may be configured to include at least one but notlimited to a user input device 1910, sensor or sensors 1912, or animaging device 1914. In some embodiments, one or more of the inputs maybe configured to be included in controlling the flow of electric current3704 from the at least one electrode 1242 through the segment of theendovascular instrument 1220. For example, the user input device 1910and the data derived from the imaging device 1914 may be included in theinput. In other non-limiting examples, the first data derived from theat least one sensor output 1912 and the data derived from the imagingdevice 1914 may be included in the input. Advantageously, the user inputdevice 1910, the first data derived from the at least one sensor output1912, and/or the data derived from the imaging device 1914 may beincluded in the input.

Consistent with disclosed embodiments, the endovascular instrument mayinclude an endovascular coil. Embodiments may further include the atleast one electrode configured to sever a portion of the endovascularcoil in contact with the at least one electrode. Consistent withdisclosed embodiments, the medical device may be configured to enableselective cutting of the endovascular coil at a plurality of locationsalong the endovascular coil via the at least one electrode.

In some examples, methods and non-transitory computer readable media forfacilitating operation of endovascular catheters are provided. Anendovascular catheter may be configured to enable passage of anendovascular device through it.

According to another embodiment of the present disclosure, medicalnon-transitory computer readable medium instructions configured to causea flow of electric current within a flexible elongated sheath in a bodyof a patient may be provided. Embodiments may further includeinstructions including the steps, in no particular order of: (i)obtaining an input for sending the electric current from an electrodepositioned within the flexible elongated sheath through a segment of anendovascular instrument received within an inner lumen of the sheath and(ii) controlling the flow of the electric current from the electrodethrough the segment of the endovascular instrument based on the input.In one example, input from the user may be indicative of a desire of theuser to initiate, stop or adjust the flow of the electric current. Insome examples, the input may include an input from a user of the medicaldevice, such as a press of a button, a turn of a dial, an input througha user interface, a voice command recognized in a captured audio datathrough voice recognition algorithms, a gesture recognized in a capturedimage data through gesture recognition algorithms, and so forth. In someexamples, the input may include data derived from at least one sensoroutput. For example, the sensor may measure electrical impedance, forexample using the electrode. In some examples, the input may includedata derived from at least one medical image, such as an x-ray image ora CT image of the medical device inside the body of the patient.

FIG. 19 illustrates an example of a medical non-transitory computerreadable medium instruction configured to cause a flow of electriccurrent. In some embodiments, and as depicted in FIG. 37, theinstructions may obtain an input 3702 from a variety of sources (notlimited to a user input device 1910, a sensor or sensors 1912, and animaging device 1914) for sending the electric current from the at leastone electrode 1242 positioned within the flexible, elongated sheath 1210through a segment of the endovascular instrument 1220 (e.g., theendovascular coil) received within an inner lumen of the flexible,elongated sheath 1214. Further, consistent with disclosed embodiments,the instruction depicted in FIG. 37 may control the flow of the electriccurrent 3704 from the at least one electrode 1242 through the segment ofthe endovascular instrument based on the input through various outputs(not limited to the electrode control component 1940, the ballooncontrol component 1942, the endovascular device advancing mechanism 1944or the coil advancing mechanism 1946).

Consistent with disclosed embodiments, the flow of the electric currentmay be controlled to cause the endovascular instrument to be severed.

FIGS. 12A and 12B illustrate an example of a medical device 1200. Asdiscussed above, embodiments may also include at least one electrode1242. The at least one electrode 1242 may further be configured to severa portion 1724 of the endovascular instrument 1220 in contact with theat least one electrode 1242 through the output or outputs of electrodecontrol component 1940 or balloon control component 1942. This mayresult in a severed coil section 1826 with a severed coil end 1826 a anda remaining coil section 1828.

Consistent with disclosed embodiments, the instructions may beconfigured to further include the steps, in no particular order of: (i)obtaining a medical image of the body captured while the sheath may bepositioned at least partially within the body and (ii) controlling theflow of the electric current from the electrode through the segment ofthe endovascular instrument based on data derived from the medicalimage. In some examples, the input may include data derived from atleast one medical image, such as an x-ray image or a CT image of themedical device inside the body of the patient. In one example, the dataderived from at least one sensor output or the data derived from atleast one medical image may be analyzed using a classification model todetermine a desired effect on the flow of the electric current.

FIG. 19 illustrates an example set of medical instructions. In someembodiments, input 3702 from an imaging device 1914 may be used tocontrol the flow of the electric current 3704 from the at least oneelectrode 1242 through the segment of the endovascular instrument 1220based on data derived from the imaging device 1914.

Consistent with disclosed embodiments, the medium may be configured tocontrol the flow of the electric current based on the data derived fromthe medical image. Embodiments may further include data derived bycalculating a convolution of at least part of the medical image toderive at least one output value of the calculated convolution. As usedherein, a one-dimensional convolution is a function that transforms anoriginal sequence of numbers to a transformed sequence of numbers. Theone-dimensional convolution may be defined by a sequence of scalars.Each particular value in the transformed sequence of numbers may bedetermined by calculating a linear combination of values in asubsequence of the original sequence of numbers corresponding to theparticular value. A value of a calculated convolution may include anyvalue in the transformed sequence of numbers. Likewise, an n-dimensionalconvolution may be a function that transforms an original n-dimensionalarray to a transformed array. The n-dimensional convolution may bedefined by an n-dimensional array of scalars (known as the kernel of then-dimensional convolution). Each particular value in the transformedarray may be determined by calculating a linear combination of values inan n-dimensional region of the original array corresponding to theparticular value. An output value of a calculated convolution mayinclude any value in the transformed array.

Embodiments may also include, in response to a first output value of thecalculated convolution, causing a first electric current to flow fromthe electrode through the segment of the endovascular instrument.

Further, embodiments may also include, in response to a second outputvalue of the calculated convolution, causing at least one of, but notlimited to: (i) stopping the flow of electric current from the electrodethrough the segment of the endovascular instrument, and (ii) causing asecond electric current to flow from the electrode through the segmentof the endovascular instrument, the second electric current differingfrom the first electric current.

According to another embodiment of the present disclosure, a method forcausing a flow of electric current within a flexible, elongated sheathin a body of a patient may be provided. Embodiments of the method may beconfigured for obtaining an input for sending the electric current froman electrode positioned within the flexible, elongated sheath through asegment of an endovascular instrument received within an inner lumen ofthe flexible, elongated sheath. Embodiments may also be configured forcontrolling the flow of the electric current from the electrode throughthe segment of the endovascular instrument based on the input in anamount sufficient to cause the endovascular instrument to be severed.

Aspects of this disclosure may relate to an endovascular device having ahollow sheath and a constrictor configured to reversibly narrow aportion of the inner lumen while the sheath is positioned, at leastpartially, within the body of a patient. In some embodiments, theendovascular device described below may be configured for delivery of anendovascular instrument. However, the endovascular device mayadditionally or alternatively be configured for use with otherinstrumentation and/or for other suitable purposes.

Various embodiments of the current disclosure may relate to anendovascular device. As used herein, an endovascular device may includeany device or instrument configured to be placed within or to operateinside a blood vessel for a medical purpose, for example to diagnoseand/or treat a patient. In some embodiments, an endovascular device mayinclude any device or instrument configured to be used during, or tootherwise facilitate, endovascular surgeries and procedures, asdescribed in greater detail herein. In some embodiments, an endovasculardevice may be configured to deliver a device, drug, or material from afirst location (e.g., a location outside the body) to a treatment sitein a blood vessel. Some non-limiting examples of endovascular devicesmay include catheters, microcatheters, balloon catheters, medicalsheaths, guidewires, coils, endovascular revascularization devices,embolization devices, or any other device configured to be placed withina blood vessel.

For example, the present application depicts different views of anexemplary endovascular device 1200. As illustrated in FIGS. 12A, 12B,and 22A-22F, exemplary endovascular device 1200 may be configured todeliver an endovascular instrument (e.g., endovascular coil 1220) to atreatment site within the body, such as aneurysm 2282. Endovasculardevice 1200 may include an elongated flexible sheath 1210, a constrictor(e.g., balloon 1260, or any other constrictor, for example as describedbelow), and, optionally, at least one electrode 1242. Additionally oralternatively to at least one electrode 1242, endovascular device 1200may include other elements, as described below.

Consistent with disclosed embodiments, the endovascular device mayinclude an elongated flexible sheath defining a lumen with an inneropening. As used herein, an elongated flexible sheath may refer to acylindrical, hollow, or enveloping structure constructed of any suitablecompliant polymeric material such as PTFE, PEBA, nylon, polyethylene,etc. Non-limiting examples of an elongated flexible sheath may include amicrocatheter, a catheter, or a tube, and may include a thin, flexibletube which may be inserted through a narrow opening into a body cavity,e.g. to treat diseases or perform a surgical procedure, as described ingreater detail herein. As used herein, a lumen with an inner opening mayinclude a central cavity or channel of a tubular or other hollowstructure. In some embodiments, the lumen may extend along the entirelength of the sheath, such that the lumen has a first opening at theproximal end of the sheath and a second opening at the distal end of thesheath. Alternatively, the lumen may extend along a portion of thesheath. The exemplary endovascular device may include a single lumen or,alternatively, multiple lumens (e.g., two lumens, three lumens, fourlumens, or any other suitable number of lumens).

Consistent with disclosed embodiments, the inner opening of the lumenmay be sized for enabling selective advancement of an endovascularinstrument therethrough. Thus, a lumen with an inner opening sized forenabling selective advancement of an endovascular instrumenttherethrough may refer to the lumen of the sheath having a large enoughcross-sectional area to allow for an endovascular instrument such as anendovascular coil to pass through the lumen, such as during use of theendovascular device for delivery of the instrument to a treatment site.As used herein, selective advancement of the instrument may refer to themovement of the endovascular instrument through the inner opening beingcontrollable (e.g., by a user of the endovascular device), such that thedirection, speed, and length of the endovascular instrument passedthrough the inner opening may be controlled. For example, selectiveadvancement of the endovascular instrument may enable proximal, distal,and rotational movement of the instrument relative to the endovasculardevice. Additionally, or alternatively, selective advancement may enablecontrol over the length of the endovascular instrument that is deliveredfrom the distal end of the endovascular device (and, thus, the length ofthe instrument remaining within the lumen of the endovascular device).

For example, as depicted in FIGS. 12A and 12B, endovascular device 1200may include microcatheter 1210, which may be an example of an elongatedflexible sheath. Microcatheter 1210, or the elongated flexible sheath,may define an inner lumen 1214 with an inner opening sized for selectiveadvancement of an endovascular instrument 1220 (such as endovascularcoil) therethrough. In addition, as shown in FIGS. 22A-22F, endovascularcoil 1220 may be configured to remain in a straightened deliveryconfiguration while constrained within endovascular device 1200 and maybend into a three-dimensional structure, such as a helix or cage, whendischarged from endovascular device 1200 into the interior volume 2284of the aneurysm.

Consistent with disclosed embodiments, the sheath may have at least afirst region and a second region. Optionally, the sheath may haveadditional regions (e.g., a third region, a fourth region, etc.). Insome embodiments, the first region of the sheath may refer to an area ofthe elongated flexible sheath beginning at a distal tip of the sheathand extending a predetermined distance in the proximal direction. Asdiscussed in detail below, the first region may optionally include atleast one electrode. The second region of the sheath may be located in aproximal direction from the first region and may encompass either theentirety or a fraction of the portion of the sheath which is not a partof the first region. In some embodiments, the second region may beimmediately adjacent to the first region, such that a proximal end ofthe first region abuts a distal end of the second region. Alternatively,one or more additional regions may be positioned in between the firstand second regions. As an example, the microcatheter 1210 depicted inFIGS. 12A and 12B may include a first region 1213 a and a second region1213 b. First region 1213 a may be located in a distal direction fromsecond region 1213 b and may include the distal end 1202 of themicrocatheter.

Consistent with disclosed embodiments, the endovascular device mayinclude an electrode within the first region of the sheath. As usedherein, an electrode may include an electrical conductor used toselectively make contact with an object and to enable an electricalcurrent to flow from the electrode to the object and/or from the objectto the electrode, as described in further detail herein. In someembodiments, multiple electrodes may be included within the first regionof the sheath. For example, the first region may include at least afirst electrode configured as a cathode and a second electrodeconfigured as an anode.

For example, as depicted in FIGS. 12A and 12B, endovascular device 1200may include a first electrode 1242 within first region 1213 a (i.e., thedistal region) of microcatheter 1210 or of the elongated flexiblesheath. Electrode 1242 may be mounted on, or otherwise connected to, theinner wall of microcatheter 1210 (or of the elongated flexible sheath)and may be located across the inner lumen from balloon 1260 and/or fromthe constrictor, such that endovascular coil 1220 may pass between them.In another example, electrode 1242 may be positioned on balloon 1260and/or on the constrictor. Endovascular device 1200 may also include asealing distal tip 1232 at its distal end; distal tip 1232 may beconfigured as a second electrode. For example, when a circuit is closedby endovascular coil 1220 contacting first electrode 1242 and distal tip(i.e., second electrode) 1232, electric current may flow betweenelectrode 1242 and distal tip 1232. In alternative embodiments, one orboth of the first and second electrodes may be situated in otherlocations within the endovascular device. Additionally or alternativelyto first electrode 1242, endovascular device 1200 may include otherelements mounted on, or otherwise connected to, the inner wall ofmicrocatheter 1210 (or of the elongated flexible sheath). The otherelements may be located across the lumen 1214 from balloon 1260 and/orfrom the constrictor, such that endovascular coil 1220 may pass betweenthe other elements and balloon 1260 and/or the constrictor. In anotherexample, the other elements may be located on balloon 1260 and/or on theconstrictor.

Some embodiments may exclude the electrode. For example, in place of anelectrode, a mechanically actuated cutter or other manner of severingthe endovascular instrument may be used. Energy may be selectivelydelivered to the electrode, for example, through an electrical wireextending from outside the body to the electrode or wirelessly.

Consistent with disclosed embodiments, the endovascular device mayinclude a constrictor associated with the first region of the sheath. Asused herein, a constrictor may include any device configured to narrow,or reduce the cross-sectional area of, a lumen, channel, or passageway,such as the inner lumen of the exemplary endovascular device. As usedherein, the term “associated with” includes embodiments in which theconstrictor is situated within the first region of the sheath (e.g.,placed within the inner lumen of the sheath, or connected to thesidewall of the sheath) and embodiments in which the constrictor isexternal to the sheath, but is configured to act on the sheath to narrowthe inner lumen. In some embodiments, the constrictor may be configuredto narrow the inner lumen of the sheath without narrowing, or otherwisealtering, the outer diameter of the sheath. Additionally, oralternatively, the constrictor may be configured to narrow the innerlumen and the outer diameter of the sheath. In some embodiments, theconstrictor may be configured to reduce a diameter of a cross-section ofthe lumen, while preserving the shape of the cross-section of the lumen(for instance, when the cross-section of the lumen is circular both whennarrowed and when not narrowed, but with different diameters). Inanother example, the constrictor may be configured to change across-sectional shape of the lumen when the lumen is constricted (forinstance, when the cross-section of the lumen is circular whenunconstricted and non-circular when constricted).

In some embodiments, the constrictor may be configured to control thedegree of constriction (i.e., narrowing) of the inner lumen of thesheath. For example, the constrictor may cause the lumen to be in anunconstricted state, in which there is no narrowing of the lumen, or ina fully-constricted state, in which the lumen is narrowed to the fullextent allowed by the constrictor. In some embodiments, the constrictormay be configured to close or obstruct the entire inner lumen while inthe fully-constricted state. The constrictor may additionally oralternatively be configured to cause the lumen to be in asemi-constricted state, such that the lumen is partially narrowed by theconstrictor.

For example, as depicted in FIGS. 16A and 17A, endovascular device 1200may include a balloon 1260, which may be configured as a constrictor.Balloon 1260 may be associated with (i.e., located within) first region1213 a of microcatheter 1210 (or with a first region of the elongatedflexible sheath). FIG. 16A and FIG. 16B show balloon 1260 in anuninflated state, in which the balloon may not protrude into orotherwise narrow inner lumen 1214; the uninflated state of balloon 1260may therefore correspond to an unconstricted state of lumen 1214. FIG.17A and FIG. 17B show balloon 1260 in an inflated state, in which theballoon protrudes into inner lumen 1214 and thus narrows the innerlumen; the inflated state of balloon 1260 may therefore correspond to aconstricted state of lumen 1214. Additionally or alternatively toballoon 1260, endovascular device 1200 may include a constrictorassociated with (i.e., located within) first region 1213 a ofmicrocatheter 1210 (or with a first region of the elongated flexiblesheath), which may be in a plurality of states, such as an unconstrictedstate, a constricted state, and so forth.

Consistent with disclosed embodiments, the constrictor may be configuredto reversibly narrow the lumen of the sheath in an area adjacent theelectrode. As used herein, “reversibly narrow” may mean that theconstrictor is configured to narrow (i.e., reduce the cross-sectionalarea of) the lumen and subsequently widen the lumen; the constrictor maywiden the lumen back to its original size or to some other size. Thus,the constrictor may effectively reverse or undo prior narrowingoperations of the lumen. Additionally, or alternatively, the constrictormay be configured to reversibly widen the lumen. That is, theconstrictor may be configured to widen the lumen from a startingcondition (e.g., from a fully-constricted state to an unconstrictedstate) and subsequently narrow the lumen, either back to its startingsize or to some other size.

In some embodiments, the constrictor may be configured to reversiblynarrow only a portion of the inner lumen, without narrowing the otherportions of the lumen. For example, and consistent with disclosedembodiments, the constrictor may be configured to reversibly narrow aportion of the inner lumen that is adjacent to the electrode; that is,the section of the sheath that encompasses the reversibly narrowedportion of the lumen also includes the electrode. In some embodiments,the electrode may be positioned on the balloon or a portion thereof (oron the constrictor or a portion thereof). Additionally, oralternatively, the electrode may be mounted on the inner wall of thesheath at a location directly across the lumen from the balloon (or fromthe constrictor). Additionally, or alternatively, the electrode may bemounted on any portion of the inner wall of the sheath between a distalend of the balloon (or of the constrictor) and a proximal end of theballoon (or of the constrictor). In another example, the electrode maybe positioned on any portion of the inner wall of the sheath.Additionally or alternatively to the electrode, other one or moreelements may be positioned on any portion of the inner wall of thesheath. For example, the other one or more elements may be positioned onthe balloon (or on the constrictor) or a portion thereof, may bepositioned on the inner wall of the sheath at a location directly acrossthe lumen from the balloon (or from the constrictor), may be positionedon any portion of the inner wall of the sheath between a distal end ofthe balloon (or of the constrictor) and a proximal end of the balloon(or of the constrictor), and so forth.

Consistent with disclosed embodiments, the reversible narrowing, by theconstrictor, of the lumen of the sheath in the area adjacent theelectrode may bring the electrode into contact with an adjacent portionof the endovascular instrument. As discussed above, the inner lumen ofthe sheath is configured to receive the endovascular instrument therein.Thus, when the portion of the lumen adjacent to the electrode isnarrowed by the constrictor, the electrode may be brought into physicalcontact with the portion of the endovascular instrument that is adjacentto it.

For example, as depicted in FIGS. 12B, 16A, and 17A, electrode 1242 andballoon 1260 may be located on opposing sides of inner lumen 1214, withelectrode 1242 positioned in between the proximal and distal ends ofballoon 1260. When balloon 1260 is inflated to cause constriction ofinner lumen 1214, the apex of the balloon may contact and push againstendovascular coil 1220, pushing the coil towards the opposite side ofthe lumen until the coil comes into physical contact with electrode1242; the contact between balloon 1260, coil 1220, and electrode 1242 isshown in FIG. 17A. Additionally or alternatively to electrode 1242,other one or more elements may be located on an opposing side to balloon1260 on lumen 1214, for example, between the proximal and distal ends ofballoon 1260. When balloon 1260 is inflated to cause constriction oflumen 1214, the apex of the balloon may contact and push againstendovascular coil 1220, pushing the coil towards the opposite side oflumen 1214 until endovascular coil 1220 comes into physical contact withthe other one or more elements. In some embodiments, balloon 1260 mayadditionally bring endovascular coil 1220 into contact with sealingdistal tip 1232 (i.e., the second electrode). For example, sealingdistal tip 1232 may be cylindrical, with an inner wall that is even withthe inner wall of microcatheter 1210 (or of the elongated flexiblesheath). Thus, when endovascular coil 1220 is pressed against electrode1242, it is also pressed against the portion of sealing distal tip 1232that is directly distal to the electrode. When it is desired to reversethe narrowing of inner lumen 1214, balloon 1260 may be uninflated byremoving the inflation fluid via inflation passage 1662. Once all of theinflation fluid is removed, balloon 1260 may return to the uninflatedstate of FIG. 16A and inner lumen 1214 may return to an unconstrictedstate.

In another example, electrode 1242 and the constrictor may be located onopposing sides of lumen 1214, with electrode 1242 positioned in betweenthe proximal and distal ends of the constrictor. When the constrictor isin constricted state to cause constriction of lumen 1214, the apex ofthe constrictor may contact and push against endovascular coil 1220,pushing endovascular coil 1220 towards the opposite side of lumen 1214until coil 1220 comes into physical contact with electrode 1242.Additionally or alternatively to electrode 1242, other one or moreelements may be located on an opposing side to the constrictor of lumen1214, for example, between the proximal and distal ends of theconstrictor. When the constrictor is in constricted state to causeconstriction of lumen 1214, the apex of the constrictor may contact andpush against endovascular coil 1220, pushing endovascular coil 1220towards the opposite side of lumen 1214 until endovascular coil 1220comes into physical contact with the other one or more elements. In someembodiments, the constrictor may additionally bring endovascular coil1220 into contact with sealing distal tip 1232 (i.e., a secondelectrode). For example, sealing distal tip 1232 may be cylindrical,with an inner wall that is even with the inner wall of microcatheter1210 (or of the elongated flexible sheath). Thus, when endovascular coil1220 is pressed against electrode 1242, it is also pressed against theportion of sealing distal tip 1232 that is directly distal to theelectrode. When it is desired to reverse the narrowing of lumen 1214,the constrictor may be turned into an unconstricted state. Once theconstrictor is in an unconstricted state, lumen 1214 may return to anunconstricted state.

Consistent with disclosed embodiments, the constrictor may be configuredto reversibly narrow the lumen and bring the electrode into contact withthe endovascular instrument (as discussed above) while at least thefirst region and the second region of the sheath are positioned within abody and in response to an input received from outside the body.Regarding the first and second regions being positioned within the body,the constrictor is configured to reversibly narrow and widen the lumenwhile the endovascular device is being used in a medical operation or isotherwise disposed within a patient, for example, within a blood vessel.The constrictor may therefore be operated without affecting thesurrounding tissue; this may be due, in part, to the fact that the outerdiameter of the endovascular device may remain constant during narrowingand widening of the inner lumen, consistent with various embodiments.

As used herein, input received from outside the body may include manualcontrol actions performed by a user of the endovascular device.Non-limiting examples of manual control actions may include useractuation of the constrictor, repositioning the endovascular deviceand/or endovascular instrument, and user actuation of the electrode. Insome examples, the manual control actions may be based on and/or includevoice commands given by the user (which may be recognized using speechrecognition algorithms), may be based on and/or include gesture commandsgiven by the user (which may be recognized using image analysis withgesture recognition algorithms), may be based on and/or includekeystrokes by the user, may include touch input from the user, may bebased on and/or include input from a user through a user interface, maybe based on and/or include textual input from the user, may be based onand/or include tactile input from the user, may be based on and/orinclude mechanical force applied by the user, and so forth.Additionally, or alternatively, input received from outside the body mayinclude control signals transmitted from a control device positionedoutside the body to a control component of the constrictor (e.g., to apump controlling inflation and deflation of a constricting balloon)and/or to another component of the endovascular device. In someembodiments, the control device may be configured to receive a commandfrom a user input device, such as by a press of a button or key, a turnof a dial, an input through a computer-generated user interface, a voicecommand recognized in captured audio data through a voice recognitionalgorithm, a gesture recognized in captured image data through a gesturerecognition algorithm, or any other action which may be performed by auser. The control unit may then transmit a corresponding control signalto the control component of the constrictor to cause the constrictor toperform the requested action (e.g., to constrict the inner lumen of thesheath). The signals from the control device may be transmitted to thecontrol component of the constrictor wirelessly and/or via a wiredconnection. Additionally, or alternatively, the control device mayreceive data, such as from a sensor associated with the endovasculardevice and/or an imaging device; may generate the control signal basedon the received data; and transmit the control signal to the controlcomponent of the constrictor. The constrictor may be configured toselectively narrow the lumen in response to the control signal receivedfrom the control device positioned outside the body. That is, theconstrictor is configured to widen or narrow the lumen of the sheath bya desired degree, based on the control signal received from the controldevice.

In the example depicted in FIGS. 12A and 12B, the endovascular devicemay include a balloon 1260 configured as a constrictor. Balloon 1260 maybe configured, while at least first region 1213 a and second region 1213b are positioned within a body and in response to an input received fromoutside the body (by, for example, one of user device 1910, sensors1912, or imaging device 1914 of FIG. 19), to reversibly narrow lumen1214 of microcatheter 1210 (or reversibly narrow the lumen of theelongated flexible sheath) in an area 1213 a adjacent electrode 1242 (asshown in FIGS. 17A, 17B, 17C, 18A, 18B, 23, and 24) to thereby bringelectrode 1242 into contact with an adjacent portion 1724 ofendovascular coil 1220, as shown in FIG. 17A. Additionally oralternatively to electrode 1242, balloon 1260 may be configured, whileat least first region 1213 a and second region 1213 b are positionedwithin a body and in response to an input received from outside thebody, to reversibly narrow lumen 1214 of microcatheter 1210 (or toreversibly narrow the lumen of the elongated flexible sheath), forexample in an area adjacent other element. In one example, the narrowingof the lumen may bring the other element into contact with an adjacentportion 1724 of endovascular coil 1220. Balloon 1260 may be configuredto selectively narrow lumen 1214 in response to a control signalreceived from a control device 1900 positioned outside the body, asshown in FIG. 19. After narrowing lumen 1214 of microcatheter 1210 (orafter narrowing the lumen of the elongated flexible sheath) in responseto the input received from outside the body, balloon 1260 may beconfigured to widen lumen 1214 in response to a second input receivedfrom outside the body, as shown in FIGS. 17B and 17C.

In the example depicted in FIGS. 12A and 12B, the endovascular devicemay include a constrictor. The constrictor may be configured, while atleast first region 1213 a and second region 1213 b are positioned withina body and in response to an input received from outside the body (by,for example, one of user device 1910, sensors 1912, or imaging device1914 of FIG. 19), to reversibly narrow lumen 1214 of microcatheter 1210(or to reversibly narrow the lumen of the elongated flexible sheath) inthe region 1213 a adjacent electrode 1242 (as shown in FIGS. 17A, 17B,17C, 18A, 18B, 23, and 24) to thereby bring electrode 1242 into contactwith an adjacent portion 1724 of endovascular coil 1220, as shown inFIG. 17A. Additionally or alternatively to electrode 1242, theconstrictor may be configured, while at least first region 1213 a andsecond region 1213 b are positioned within a body and in response to aninput received from outside the body, to reversibly narrow lumen 1214 ofmicrocatheter 1210 (or to reversibly narrow the lumen of elongatedflexible sheath), for example in an area adjacent other element. In oneexample, the narrowing of lumen 1214 may bring the other element intocontact with an adjacent portion 1724 of endovascular coil 1220. Theconstrictor may be configured to selectively narrow lumen 1214 inresponse to a control signal received from a control device 1900positioned outside the body, as shown in FIG. 19. After narrowing lumen1214 of microcatheter 1210 (or after narrowing the lumen of theelongated flexible sheath) in response to the input received fromoutside the body, the constrictor may be configured to widen lumen 1214in response to a second input received from outside the body, as shownin FIGS. 17B and 17C.

In some embodiments, the constrictor may be configured to constrict thefirst region of the sheath, and automatically unconstrict the firstregion of the sheath after a specified period of time. For instance, acontrol device may cause the constrictor to automatically unconstrictthe first region of the sheath after 0.1s, 1s, 2s, 5s, 10s, or any otherappropriate interval of time elapses after constriction which will notharm the endovascular device, the endovascular instrument, or thepatient. In some embodiments, after narrowing the lumen of the sheath inresponse to the input received from outside the body, the constrictormay be configured to widen the lumen in response to a second inputreceived from outside the body. In some cases, the widening in responseto a second input may bring the endovascular instrument out of contactwith the electrode. Widening the lumen may include unconstricting thefirst region of the sheath.

Consistent with disclosed embodiments, the endovascular device may beconstructed such that during constriction of the first region of thesheath, the second region of the sheath is configured to remainunconstricted. Thus, the constrictor may be configured to causeconstriction of a portion of the lumen, without causing constriction ofother portions of the lumen (such as the section of the lumen within thesecond region of the sheath). In some embodiments, the second region ofthe sheath may fall outside the area that is acted upon by theconstrictor. In alternative embodiments, the constrictor may beconfigured to selectively and independently constrict the first regionof the sheath and the second region of the sheath. In such embodiments,the constrictor may cause narrowing of the lumen within the first regionand may cause the lumen within the second region to remain unchanged.FIGS. 16C and 17C depict an example of a second region of the sheath1210 when inner lumen 1214 is unconstricted and constricted,respectively. In this example, the second region may not include anypart of balloon 1260 (and/or of the constrictor); thus, when the balloonis inflated (or when the constrictor is in constricted state), it maynot protrude into the second region or otherwise change thecross-sectional shape of inner lumen 1214 within the second region.Instead, the diameter and shape of inner lumen 1214 is the same in FIG.16C and in FIG. 17C.

Consistent with disclosed embodiments, a first section of the lumenwithin the first region of the sheath may have a circular cross-sectionduring non-constriction. In some embodiments, the first section of thelumen may be adjacent to, or bounded by, a portion of the constrictor.Additionally, or alternatively, the first section of the lumen may beadjacent to, or bounded by, the electrode. Consistent with disclosedembodiments, the constrictor may be configured to cause thecross-section of the first section of the lumen in an area of theconstrictor to become non-circular. In some embodiments, the constrictormay be configured to protrude into the first section of the lumen,causing the lumen to have a non-circular cross-sectional shape (i.e.,due to the inward protrusion of the constrictor). Consistent withdisclosed embodiments, a second section of the lumen within the secondregion of the sheath may have a circular cross-section duringconstriction and during non-constriction. For example, and as discussedabove, the cross-sectional shape of the lumen within the second regionmay remain constant between constriction and non-constriction. Forexample, FIGS. 16B and 17B depict an exemplary first region of sheath1210 in an unconstricted state and in a constricted state, respectively,while FIGS. 16C and 17C depict an exemplary second region of sheath 1210in the unconstricted state and constricted state, respectively. As shownin FIGS. 16B and 16C, inner lumen 1214 has a circular cross-section inboth the first region and second region. However, in the first regiondepicted in FIG. 17B, inner lumen 1214 has a non-circular cross-section(specifically, a moon-shaped cross-section) because balloon 1260 (and/orthe constrictor) protrudes into the inner lumen at the first region. Incontrast, in the second region depicted in FIG. 17C, inner lumen 1214has the same circular cross-section as in the unconstricted state sincethe second region of sheath 1210 may not include any part of balloon1260 (or of the constrictor).

Consistent with disclosed embodiments, during constriction, theconstrictor may be configured to obstruct axial advancement of theendovascular instrument within the first region of the sheath. In someembodiments, the constrictor may be configured to either completelyblock the lumen or narrow the lumen to such an extent that there isinsufficient space for the endovascular instrument to pass theconstrictor. An example is shown in FIG. 23: endovascular device 1200may include a constrictor (such as balloon 1260, or any other type ofconstrictor as described herein) configured to be constricted (forexample, inflated) until apex 1562 contacts the opposite side of thesheath 1210. Since balloon 1260 (or the constrictor) fills the innerlumen 1214, endovascular coil 1220 is blocked from advancing proximallypast the balloon (or the constrictor). In some alternative embodiments,balloon 1260 (or the constrictor) may only partially fill the innerlumen, but may still obstruct axial advancement of coil 1220 by leavinginsufficient open space in the lumen for the coil to fit through.

In some embodiments, when the endovascular instrument is locatedadjacent to the constrictor, the constrictor may be configured to expandaround the instrument and exert a grasping-type force upon it. Forexample, the constrictor may be configured to cause exertion of astronger friction force on the endovascular instrument when constrictedthan when unconstricted. As a result, the constrictor may hold theendovascular instrument in place and preventing it from moving. Anexample is shown in FIG. 24: endovascular device 1200 may include aconstrictor (such as balloon 1260, or any other type of constrictor asdescribed herein) configured to expand around coil section 2321 andexert a grasping-type force upon it. As a result, balloon 1260 (or theconstrictor) may secure endovascular coil 1220 against axial androtational movement until coil section 2321 is released from the balloonand/or from the constrictor (e.g., by deflating the balloon, byunconstricting the constrictor, etc.).

In some embodiments, at least a first portion of the constrictor may belocated within the lumen of the sheath during constriction, and at leasta second portion of the constrictor may be located outside the lumen ofthe sheath, adjacent an external surface of the sheath.

Consistent with disclosed embodiments, the constrictor may include atleast one obstructer. As used herein, an obstructer may refer to astructure configured to narrow a lumen by protruding inward from thelumen wall into the interior of the lumen. In some embodiments, theendovascular device may include a single obstructer. Alternatively, theendovascular device may include two obstructers, three obstructers, fourobstructers, or any other suitable number of obstructers. In someembodiments, the at least one obstructer may include at least twoobstructers spaced about a circumference of the lumen of the sheath. Forexample, the at least two obstructers may be spaced at a regularinterval around the circumference (e.g., three obstructers may be spaced120-degrees apart); alternatively, the at least two obstructers may bespaced at some other, non-regular interval around the circumference. Insome embodiments, the at least one obstructer may include a plurality ofobstructers located substantially at a same distance from a distal tipof the endovascular device. As used herein, “substantially at a samedistance” from the distal tip may include obstructers located at thesame distance from the distal tip and obstructers having respectivedistances from the distal tip where the differences in the distancesfrom the distal tip are less than a particular length. For example, theparticular length may be shorter than 1 mm, shorter than 5 mm, shorterthan 1 cm, shorter than 2 cm, shorter than 1 inch, shorter than 2inches, and so forth. Additionally, or alternatively, the at least oneobstructer may include a plurality of obstructers, each located atdiffering distances from the distal tip of the endovascular device.

In some embodiments, the at least one obstructer may be mounted on, orotherwise connected to, the inner surface of the sheath and may beenlarged (e.g., mechanically expanded, inflated with fluid, etc.) inorder to constrict the inner lumen. In alternative embodiments, the atleast one obstructer may be connected to the sheath at a locationoutside the lumen and may be configured to protrude into the inner lumento cause constriction. For example, the at least one obstructer may beconfigured to lie substantially flush with an outer surface of the firstregion of the sheath when the first region is non-constricted, and toprotrude into the lumen of the sheath when the first region isconstricted. For example, FIGS. 17A, 15A, and 15B depict an example inwhich balloon 1260 may correspond to the at least one obstructer. Outerportion 1564 of the balloon may be secured to the outer surface ofsheath 1210 (e.g., by adhesive or a mechanical connection), while innerportion 1562 of the balloon may be configured to pass through the sheathopening 1216 and into the inner lumen 1214 when the balloon is inflated.In the inflated state, balloon 1260 is configured as an obstructer thatprotrudes into, and thus narrows, the inner lumen 1214. In anotherexample, an outer portion of the constrictor may be secured to the outersurface of sheath 1210 (e.g., by adhesive or a mechanical connection),while inner portion 1562 of the constrictor may be configured to invadelumen 1214 when the constrictor is constricted. In the constrictedstate, the constrictor may be configured as an obstructer that protrudesinto, and thus narrows, the lumen 1214.

Consistent with disclosed embodiments, the at least one obstructer mayinclude a selectively inflatable balloon configured for expansion intothe lumen of the sheath when inflated. As used herein, a balloon mayrefer to a device that may be inflated with fluid that is delivered tothe balloon via an inflation fluid conduit or passageway. In oneexample, a balloon may be constructed of an airtight flexible bag. Inthe absence of external obstructions, in one example, a balloon may beconfigured to inflate and/or deflate symmetrically (for example, in anaxis of symmetry, in a plane of symmetry, or in any other symmetricalmanner), while in another example, a balloon may be configured toinflate and/or deflate asymmetrically. As used herein, selectiveinflation may refer to controlled inflation or deflation of the balloonto a desired degree. For example, the balloon may be selectivelyinflated to a desired semi-inflated state (rather than proceeding to afully-inflated state). In another example, the inflated balloon may beselectively deflated until a desired state of inflation is achieved.

In some embodiments, the system controller may be configured to performan automated process for determining when to inflate and/or deflate theballoon (and/or when to constrict and when to unconstrict theconstrictor). For example, based on an analysis of data captured using asensor (such as medical images, electrical impedance data, mechanicaltension data, or any other data which may relay information from insidethe body), a desired of a particular state of the balloon may bedetermined and, if the balloon is not in a desired particular state, thecontroller may output a signal to a balloon control component (e.g., aninflation pump) to inflate or deflate the balloon until the desiredparticular state is achieved. Additionally, or alternatively, a user mayinput control signal to the system controller to selectively inflate ordeflate the balloon. In another example, based on an analysis of datacaptured using a sensor (such as medical images, electrical impedancedata, mechanical tension data, or any other data which may relayinformation inside the body), a desire of a particular state of theconstrictor may be determined and, if the constrictor is not in adesired particular state, the controller may output a signal to changethe state of the constrictor until the desired particular state isachieved.

Consistent with disclosed embodiments, the endovascular instrument maybe an endovascular coil configured for bending within a hollow bodystructure upon discharge from the sheath. As used herein, anendovascular coil may refer to a helically-coiled structure, oftenformed from a metallic wire, configured to be delivered into an aneurysmor another hollow body structure in order to pack the interior volume ofthe aneurysm and reduce blood circulation thereto. As discussed herein,the endovascular coil may be configured for bending within a hollow bodystructure (e.g., in the first manner or second manner discussed above)upon the removal of a restraining force from the coil, such as when thecoil is discharged from the distal end of the sheath and delivered intothe aneurysm. In some embodiments, the electrode may be located in adistal region of the sheath. In some embodiments, the electrode may beconfigured to sever the endovascular coil following discharge of atleast a portion of the coil from the sheath. As used herein, to severthe coil may mean to partition or separate the coil into multipledistinct pieces. As discussed in further detail herein, the endovascularcoil may be advanced through the endovascular device until a desiredlength of coil has been advanced beyond the distal end of the device andto a delivery location (e.g., into an aneurysm). The electrode may thenbe actuated to pass electric current to the coil in a sufficient amountto sever the coil at the portion thereof that is adjacent to theelectrode.

In some embodiments, the electrode may be configured to make physicalcontact with the endovascular instrument during constriction to enablethe electrode to deliver energy to the endovascular instrument. As usedherein, physical contact may include the electrode and the endovascularinstrument directly touching each other or being close enough thatsufficient levels of electric current may be delivered from theelectrode to the endovascular instrument to sever the instrument. Insome embodiments, the constrictor may be configured to move theelectrode closer to the endovascular instrument, or vice versa, untilthe electrode and instrument are brought into physical contact. That is,consistent with disclosed embodiments, the constrictor may be configuredto press the electrode and the endovascular instrument together in amanner reducing electrical impedance during energy delivery. As a resultof the reduces impedance, the electrode may be configured to deliversufficient electric current to the endovascular instrument to sever theinstrument. Additionally, or alternatively, the constrictor may beconfigured such that constriction of the first region of the sheathcloses an electrical circuit including the electrode and theendovascular instrument, such as by bringing the instrument intophysical contact with the electrode and with a second electrode tocomplete the circuit.

For example, electrode 1242 depicted in FIGS. 12A, 12B, 17A, and 18A maybe configured to make physical contact with endovascular coil 1220during constriction to enable electrode 1242 to deliver energy toendovascular coil 1220, balloon 1260 (or the constrictor) may beconfigured to press electrode 1242 and endovascular coil 1220 togetherin a manner reducing electrical impedance during energy delivery, andballoon 1260 (or the constrictor) may be configured such thatconstriction of first region 1213 a of microcatheter 1210 (or of thefirst region of the elongated flexible sheath) closes an electricalcircuit including electrode 1242 and endovascular coil 1220, as shown inFIGS. 17A and 18A. A first section of lumen 1214 within first region1213 a may have a circular cross-section during non-constriction, andballoon 1260 (or the constrictor) may be configured to cause thecross-section of the first section of lumen 1214 in an area of balloon1260 (or of the constrictor) to become non-circular, as shown in FIG.17B. Additionally or alternatively, endovascular device 1200 may beconstructed such that during constriction of first region 1213 a ofmicrocatheter 1210, second region 1213 b of microcatheter 1210 may beconfigured to remain unconstricted, as shown in FIG. 18A. Additionallyor alternatively, endovascular device 1200 may be constructed such thatduring constriction of first region 1213 a of the sheath 1210, secondregion 1213 b of the sheath 1210 may be configured to remainunconstricted.

Consistent with disclosed embodiments, the electrode may be configuredto deliver energy in an amount sufficient to sever the endovascularinstrument while at least the first region and the second region of thesheath are positioned within the body. Thus, the endovascular instrumentmay be successfully severed without risk of injury to the patient. Insome examples, the amount sufficient to sever the endovascularinstrument may be a function of the characteristics of the endovascularinstrument, such as a material composition of the endovascularinstrument, a structure of the endovascular instrument, a diameter ofthe endovascular instrument, an electrical resistance of theendovascular instrument, and so forth. Moreover, in some examples, theamount sufficient to sever the endovascular instrument may be a functionof the manner in which the energy is delivered, such as the distributionof energy delivered over time, the concentration of energy delivered ata specific portion of the endovascular instrument, and so forth. Forsome common endovascular coils, delivering energy of between 10 to 300watt per second for a duration of 0.1 to 10 seconds is typically anamount sufficient to sever the endovascular instrument, but otheramounts may be required as described above.

Disclosed embodiments may further include electrical circuitry, whereinthe electrode may be configured for connection to the circuitry forselectively delivering the energy to the electrode. Electrical circuitrymay include an interconnection of electrical components configured todeliver current via the electrode in such a way as to separate anendovascular instrument in two. The electrical circuitry may have atleast a first state and a second state, wherein at the first state theelectrical circuitry may be configured to cause a first electricalvoltage between two particular points, and at the second state theelectrical circuitry may be configured to cause a second electricalvoltage between the two particular points, the second electrical voltagediffering from the first electrical voltage. The electrical circuitrymay be disposed such that no current is transferred to a patient beingtreated in a way which could cause bodily harm.

For example, as depicted in FIGS. 12A, 12B, 18A, and 18B, endovasculardevice 1200 may include an electrode 1242 within the first region 1213 aof the sheath (for example, of microcatheter 1210). Electrode 1242 maybe located in a distal region 1213 a, or first region 1213 a, ofmicrocatheter 1210 (or in a distal region or the first region of theelongated flexible sheath) and may be configured to sever endovascularcoil 1220 following discharge of at least a portion of the coil from thesheath, as depicted in FIGS. 18A and 18B. Electrode 1242 may beconfigured to deliver energy in an amount sufficient to severendovascular coil 1220 while at least first region 1213 a and secondregion 1213 b of microcatheter 1210 (or at least the first region andthe second region of the elongated flexible sheath) are positionedwithin the body, as depicted in FIGS. 22A-22C. As another example, asdepicted in FIGS. 12A and 12B, endovascular device 1200 may includeelectrical circuitry 1243, including wires connecting electrode 1242 toa power source. Additionally or alternatively to electrode 1242,endovascular device 1200 may include other one or more elements withinthe first region 1213 a of the sheath (for example, the microcatheter1210). The other element may be located in a distal region 1213 a, orfirst region 1213 a, of microcatheter 1210 (or may be located in thedistal region or the first region of the elongated flexible sheath).

Consistent with disclosed embodiments, the constrictor may be configuredto selectively narrow the lumen in response to at least one of: a changein temperature of at least a portion of the constrictor, delivery ofelectric current to the constrictor, an application of electromagneticforce on the constrictor, or an application of mechanical force on theconstrictor. A non-limiting example of a constrictor may include aconstrictor configured to constrict and/or to unconstrict in response toa change in temperature of at least a portion of the constrictor. Forexample, the constrictor may include a shape-memory element that narrowsthe lumen when the transformation temperature is reached and/orunconstrict the lumen when the temperature falls below a threshold.Further, the temperature of the shape-memory element may becontrollable, for example, by an interventional radiologist. Forexample, the shape-memory element may be configured to heat in responseto flow of electric current passing through it or through an elementadjunct to it.

Another non-limiting example of a constrictor may include a constrictorconfigured to constrict and/or to unconstrict in response to delivery ofelectric current to the constrictor, for example, as described above. Inone example, the electric current may flow through an electrical wireextending from outside the body and connected to the constrictor.

Yet another non-limiting example of a constrictor may include aconstrictor configured to constrict and/or to unconstrict in response tosignificant change in a magnetic field. An additional non-limitingexample of a constrictor may include a constrictor configured toconstrict and/or to unconstrict in response to an application of amechanical force (such as pressure, stress, or any other applicablemechanical force) on the constrictor. For example, the constrictor mayinclude a moveable element configured to be in a first position thatnarrows the lumen when a first mechanical force is exerted on themoveable element, and/or configured to be in a second position that maynot narrow the lumen when a second mechanical force is exerted on themoveable element. In one example, an interventional radiologist maycause an exertion of a mechanical force on the moveable portion, forexample by pulling and/or pushing a wire extended from outside the bodyand connected to the moveable element, by increasing and/or decreasinggas or liquid pressure in a tube extending from outside the body andconnected to the moveable element, by pushing a volume of gas or liquidinto a tube extending from outside the body and connected to themoveable element.

Various embodiments of the current disclosure include an endovasculartreatment method. An endovascular treatment method may refer to anaction or set of actions occurring inside a blood vessel for healing apatient or a condition medically or surgically. For example, anendovascular treatment method may include a set of actions for treatingan aneurysm. The endovascular treatment method may correspond toendovascular treatment method 2800 of FIG. 28.

The endovascular treatment method of the current disclosure may includedelivering an endovascular instrument to human vasculature via a sheathhaving an electrode therein, which may include inserting a sheath havingan electrode disposed near an inserted end of the sheath into a vesselof a patient (e.g., a blood vessel), and delivering an endovascularinstrument through the sheath. Delivering an endovascular instrument tohuman vasculature via a sheath having an electrode therein maycorrespond to step 2802 of FIG. 28.

The endovascular treatment method of the current disclosure may furtherinclude, while a portion of the sheath having the electrode is within abody, reversibly constricting the portion of the sheath having theelectrode to narrow a lumen within the sheath and thereby cause theelectrode and the endovascular instrument to make physical contact. Aportion of the sheath having the electrode being within a body may referto the sheath not having to be fully disposed within the body to performthe step of constricting the portion of the sheath having the electrode.Constricting the portion of the sheath having the electrode may beperformed by a constrictor, as described in greater detail herein.Causing the electrode and the endovascular instrument to make physicalcontact may be advantageous to reduce electrical impedance in anelectrical circuit associated with the endovascular instrument and theelectrode, as described in greater detail herein. In some embodiments,constricting the sheath may occur via expansion of a balloon within thelumen of the sheath, as described in greater detail herein. Reversiblyconstricting the portion of the sheath having the electrode to narrow alumen within the sheath and thereby cause the electrode and theendovascular instrument to make physical contact, while a portion of thesheath having the electrode is within a body, may correspond to step2804 of FIG. 28.

The endovascular treatment method of the current disclosure may furtherinclude, while the portion of the sheath having the electrode isconstricted, supplying electrical energy to the electrode, to therebydeliver electrical energy to the endovascular instrument via theelectrode, as described in greater detail herein. In some embodiments,supplying the electrical energy to the electrode may include deliveringelectrical energy in a quantity sufficient to sever the endovascularinstrument, as described in greater detail herein. Supplying electricalenergy to the electrode, to thereby deliver electrical energy to theendovascular instrument via the electrode, while the portion of thesheath having the electrode is constricted, may correspond to step 2806of FIG. 28.

Various embodiments of the current disclosure include non-transitorycomputer readable media containing instructions for endovasculartreatment. Consistent with other disclosed embodiments,computer-readable media may store program instructions, which areexecutable by at least one processing device and perform any of thesteps and/or methods described herein. The instructions for endovasculartreatment may be performed in conjunction with endovascular treatmentmethod 2800 of FIG. 28 by, for example, processor 1902 of control unit1900 of FIG. 19.

The instructions for endovascular treatment of the current disclosuremay include obtaining an input corresponding to delivery of anendovascular instrument to human vasculature via a sheath having anelectrode therein, which may refer to instructions for receiving,retrieving, or otherwise acquiring an input which confirms delivery ofan endovascular instrument (e.g., an endovascular coil) to humanvasculature via a sheath having an electrode therein, as described ingreater detail herein.

By way of example, processor 1902 of FIG. 19 may receive a confirmationfrom at least one of endovascular device advancing mechanism 1944 and/orcoil advancing mechanism 1946 that delivery of endovascular coil 1220 ofFIGS. 22E-22F to aneurysm 2282 is complete. The instructions ofobtaining an input corresponding to delivery of an endovascularinstrument to human vasculature via a sheath having an electrode thereinmay be performed in conjunction with step 2802 of FIG. 28.

The instructions for endovascular treatment of the current disclosuremay further include, based on the input, and while a portion of thesheath having the electrode is within a body, causing reversibleconstriction of the portion of the sheath having the electrode to narrowa lumen within the sheath and thereby cause the electrode and theendovascular instrument to make physical contact, which may refer tocausing reversible constriction of the portion of the sheath having theelectrode based on a confirmation that delivery of the endovascularinstrument was successful, as described in greater detail herein. Insome embodiments, constricting the sheath may occur via expansion of aballoon (or via constriction of the constrictor) within the lumen of thesheath, as described in greater detail herein.

By way of example, processor 1902 of FIG. 19 may send a signal viaconstrictor control component 1942 to cause reversible constriction ofportion 1213 a of microcatheter 1210 (or of a portion of the elongatedflexible sheath) having electrode 1242 (and/or another element) tonarrow lumen 1214 within microcatheter 1210 and thereby cause electrode1242 (and/or the other element) and endovascular coil 1220 to makephysical contact, as shown in FIG. 17A. In some embodiments,constricting microcatheter 1210 (or constricting the elongated flexiblesheath) may occur via constriction of the constrictor (for example, viaexpansion of balloon 1260) within lumen 1214 of microcatheter 1210 (orwithin the lumen of the elongated flexible sheath). The instructions of,based on the input, and while a portion of the sheath having theelectrode is within a body, causing reversible constriction of theportion of the sheath having the electrode to narrow a lumen within thesheath and thereby cause the electrode and the endovascular instrumentto make physical contact may be performed in conjunction with step 2804of FIG. 28.

The instructions for endovascular treatment of the current disclosuremay further include, while the portion of the sheath having theelectrode is constricted, controlling supply of electrical energy to theelectrode, to thereby deliver electrical energy to the endovascularinstrument via the electrode, which may refer to delivering electricalenergy to the endovascular instrument via the electrode based on theportion of the sheath having the electrode being constricted, asdescribed in greater detail herein. In some embodiments, supplying theelectrical energy to the electrode may include delivering electricalenergy in a quantity sufficient to sever the endovascular instrument, asdescribed in greater detail herein.

By way of example, processor 1902 of FIG. 19 may, while portion 1213 aof microcatheter 1210 (or while a portion of the elongated flexiblesheath) is constricted (which may be determined by one or more ofelectrode control component 1940, constrictor control component 1942,coil advancing mechanism 1946, sensors 1912, and/or imaging device 1914sending a signal to processor 1902) controlling supply of electricalenergy to electrode 1242, to thereby deliver electrical energy toendovascular coil 1220 via electrode 1242, as shown in FIGS. 18A and18B. In some embodiments, supplying the electrical energy to electrode1242 may include delivering electrical energy in a quantity sufficientto sever endovascular coil 1220, as shown in FIGS. 18A and 18B. Theinstructions of, while the portion of the sheath having the electrode isconstricted, controlling supply of electrical energy to the electrode,to thereby deliver electrical energy to the endovascular instrument viathe electrode may be performed in conjunction with step 2806 of FIG. 28.

Aspects of this disclosure may relate to an endovascular apparatushaving an elongated catheter, a balloon, and a tube configured to causeexpansion of the balloon into an inner lumen of the catheter when theballoon is inflated. In some embodiments, the endovascular apparatus maybe configured to secure or obstruct axial advancement of a medicalinstrument within the inner lumen of the catheter. However, theendovascular apparatus may additionally or alternatively be configuredfor use with other instrumentation and/or for other suitable purposes.

Various embodiments of the current disclosure may relate to anendovascular apparatus. As used herein, and endovascular apparatus mayinclude any device or instrument configured to be placed within or tooperate inside a blood vessel for a medical purpose, for example, todiagnose and/or treat a patient. In some embodiments, an endovascularapparatus may include any device or instrument configured to be usedduring, or to otherwise facilitate, endovascular surgeries andprocedures, as described in greater detail herein. In some embodiments,an endovascular apparatus may be configured to deliver a device, drug,or material from a first location (e.g., a location outside the body) toa treatment site in a blood vessel, and may be configured to secure orobstruct axial advancement of said device, drug, or material. Somenon-limiting examples of endovascular devices may include catheters,microcatheters, balloon catheters, medical sheaths, guidewires, coils,endovascular revascularization devices, embolization devices, or anyother device configured to be placed within a blood vessel

For example, the present application depicts different views of anendovascular apparatus 1200. As illustrated in FIGS. 12A, 12B, and22A-22F, endovascular apparatus 1200 may be configured to deliver amedical instrument 1220 (e.g., an endovascular coil) to a treatment sitewithin the body, such as aneurysm 2282. Endovascular device 1200 mayinclude a catheter 1210, a balloon 1260, and, optionally, at least oneelectrode 1242.

Consistent with disclosed embodiments, the endovascular apparatus mayinclude an elongated catheter having an inner lumen extendingtherethrough. As used herein, an elongated catheter may refer to acylindrical, hollow, or enveloping structure constructed of any suitablecompliant polymeric material such as PTFE, PEBA, nylon, polyethylene,etc. Non-limiting example of an elongated catheter may include amicrocatheter, a catheter, or a tube, and may include a thin, flexibletube which may be inserted through a narrow opening into a body cavity,e.g., to treat diseases or perform a surgical procedure, as described ingreater detail herein. As used herein, an inner lumen extendingtherethrough may include a central cavity or channel of a tubular orother hollow structure. In some embodiments, the inner lumen may extendalong the entire length of the elongated catheter, such that the innerlumen has a first opening at a proximal end of the elongated catheterand a second opening at a distal end of the elongated catheter.Alternatively, the inner lumen may extend along a portion of theelongated catheter. The exemplary endovascular apparatus may include asingle inner lumen or, alternatively, multiple inner lumens (e.g., twoinner lumens, three inner lumens, four inner lumens, or any othersuitable number of inner lumens).

For example, as depicted in FIGS. 12A and 12B, endovascular apparatus1200 may include catheter 1210, which may be an example of an elongatedcatheter. Catheter 1210, or the elongated catheter, may define an innerlumen 1214.

Consistent with disclosed embodiments, the endovascular apparatus mayinclude a balloon affixed to the catheter for expansion into the innerlumen of the catheter when the balloon is inflated. As used herein, aballoon may refer to a device that may be inflated with fluid that isdelivered to the balloon via an inflation fluid conduit or passageway.In one example, a balloon may be constructed of an airtight flexiblebag. In at least one example, the balloon may be made of at least one ofpolyester and/or nylon. A non-limiting example of such polyester mayinclude polyethylene terephthalate. In another example, the balloon maybe made of a plastic polymer, such as polyvinyl chloride, polyethylene,or other appropriate plastic polymers which may allow the balloon toinflate and deflate into the inner lumen of the catheter without causingdamage to itself or the catheter. In another example, the balloon may bemade of reinforced polyurethane. In yet another example, the balloon maybe made of polyether block amide. In the absence of externalobstructions, in one example, a balloon may be configured to inflateand/or deflate symmetrically (for example, in an axis of symmetry, in aplane of symmetry, or in any other symmetrical manner), while in anotherexample, a balloon may be configured to inflate and/or deflateasymmetrically. The balloon may be affixed to the catheter such that itsurrounds and/or covers at least a portion of the catheter or an entiresection of the catheter. In some examples, the balloon may be affixed tothe catheter with adhesive, with staples, with stitches, by fusing themtogether (for example, welding them together), by fabricating theballoon and the catheter together, by planting at least part of theballoon in the catheter, and so forth. In one example, the balloon maybe directly affixed to the catheter. For example, an extremity of theballoon may be affixed an extremity of the catheter. For example, thisextremity of the catheter may be part of the inner wall of the catheter,may be part of an external wall of the catheter, may be part of a distaltip of the catheter, and so forth. In another example, the balloon maybe indirectly affixed to the catheter, for example through a thirdobject. For example, the balloon may be affixed to the third object, andthe third object may be affixed to the catheter. In one example, aparticular part of the balloon may be immovable with respect to aparticular part of the catheter. In another example, a particular partof the balloon may be free to move within a selected range of distancesfrom a particular part of the catheter. The balloon may expand into theinner lumen via an opening in the catheter when fluid is delivered tothe balloon via an inflation fluid conduit or passageway, causing theballoon to inflate. In some examples, the endovascular apparatus mayinclude a balloon not affixed to the catheter for expansion into theinner lumen of the catheter when the balloon is inflated. For example,the balloon may be situated in the inner lumen of the catheter. Inanother example, the balloon may be free to move within the inner lumenof the catheter and/or outside the inner lumen of the catheter. In someembodiments, the balloon may be situated outside of the inner lumen ofthe catheter when the balloon is deflated. In other examples, at leastpart of the balloon may be situated inside the inner lumen of thecatheter when the balloon is deflated.

For example, as depicted in FIGS. 12A, 12B, 15A-15B, and 23-24,endovascular apparatus 1200 may include balloon 1260 affixed to catheter1210 for expansion into inner lumen 1214 when balloon 1260 is inflated.Balloon 1214 may be affixed to catheter 1210 such that it surroundsand/or covers at least a portion of catheter 1210, as shown in FIGS.15A-15B. As another example, balloon 1260 may be situated outside ofinner lumen 1214 when balloon 1260 is deflated, as shown in FIG. 15A,and may expand into inner lumen 1214 when 1260 is inflated, as shown inFIG. 15B.

Consistent with disclosed embodiments, the endovascular apparatus mayinclude a tube secured relative to the balloon, wherein the tube may beconfigured to enable selective inflation and deflation of the balloon.The tube may refer to a cylindrical, hollow, or enveloping structureconstructed of any suitable compliant polymeric material such as PTFE,PEBA, nylon, polyethylene, etc., which may envelop the catheter tocreate an airtight inflation fluid conduit or passageway between thetube and the catheter. The tube may include a thin, flexible tube orouter sheath which may be inserted through a narrow opening into a bodycavity, e.g., to treat diseases or perform a surgical procedure, asdescribed in greater detail herein. The tube may be secured relative tothe balloon due to a distal tip securing the tube and the microcathetertogether. The tube may be configured to enable selective inflation anddeflation of the balloon by delivering a fluid through the airtightinflation fluid conduit or passageway created by the space between thetube and the catheter.

As used herein, selective inflation may refer to controlled inflation ordeflation of the balloon to a desired degree, as described in greaterdetail herein. For example, the balloon may be selectively inflated to adesired semi-inflated state (rather than proceeding to a fully-inflatedstate). In another example, the inflated balloon may be selectivelydeflated until a desired state of inflation is achieved. In someembodiments, the balloon may be selectively inflated and/or deflated toany state within a predetermined viable inflation range. In anotherexample, the balloon may be selectively inflated and/or deflated to oneof a finite number of states (for example, two states, three states,more than three states, and so forth). For instance, the balloon may beselectively inflated and/or deflated to two states, an inflated stateand a deflated state. In another example, the balloon may be selectivelyinflated and/or deflated to one deflated state and multiple inflatedstates of different inflating levels.

For example, as shown in FIGS. 12A-18B, endovascular apparatus 1210 mayinclude a tube 1230 secured relative to balloon 1260, wherein tube 1230may be configured to enable selective inflation and deflation of balloon1260 by delivering an inflation fluid through an inflation passage 1662,created by the space between tube 1230 and catheter 1210.

Consistent with disclosed embodiments, an outer diameter of a portion ofthe catheter adjacent the balloon may be substantially the same when theballoon is inflated and when the balloon is deflated. The portion of thecatheter adjacent the balloon may be a section of the catheter near toor surrounded by the balloon. During inflation and deflation, the changeto the outer diameter of the portion of the catheter adjacent theballoon may be less than 20% of the original outer diameter, less than10%, less than 1%, less than 0.5%, less than 0.1%, or less than 0.01%.Alternatively, the outer diameters may be identical or substantiallyidentical during inflation and deflation of the balloon. For example,when balloon 1260 is inflated, as in FIG. 17B, the outer diameter of theportion of catheter 1210 adjacent balloon 1260 is substantially the sameas when balloon 1260 is deflated, as in FIG. 16B. In other examples, theouter diameter of a portion of catheter 1210 adjacent balloon 1260 maybe substantially different when the balloon is inflated and when theballoon is deflated. For example, during inflation and deflation, thechange to the outer diameter of the portion of the catheter adjacent theballoon may be more than 20% of the original outer diameter.

In some embodiments, the balloon may be situated in an opening formed ina side wall of the catheter. The opening may be a hole or an aperture inthe wall of the catheter which may allow the balloon to expand into theinner lumen of the catheter. In some embodiments, the catheter mayinclude two or more openings formed in the side wall of the catheter. Insome embodiments, the balloon may be configured to expand through theopening and into the inner lumen of the catheter when the balloon isinflated. The balloon may be inflated and deflated by transferring amaterial to and from the balloon from outside the catheter, as describedin greater detail herein. When the catheter includes two or moreopenings formed in the side wall of the catheter, the balloon may beconfigured to expand through the two or more openings. For example, asshown in FIGS. 12A-18B, balloon 1260 may be situated in an opening 1216formed in a side wall of catheter 1210. In some embodiments, balloon1260 may be configured to expand through opening 1216 and into innerlumen 1214 of catheter 1210 when balloon 1260 is inflated, as shown inFIG. 17A. In some embodiments, catheter 1210 may include two or moreopenings formed in the side wall of the catheter.

In some embodiments, an internal volume of the portion of the catheteradjacent the balloon may be smaller when the balloon is inflated thanwhen the balloon is deflated. The internal volume of the portion of thecatheter adjacent the balloon may refer to a space within the catheterdefined by the cross-section multiplied by the length of the portion ofthe catheter adjacent the balloon, the portion of the catheter adjacentthe balloon being described in greater detail herein. For instance,inflation of the balloon may cause the internal volume to be more than5% smaller than when the balloon is deflated, more than 10% smaller,more than 20% smaller, more than 40% smaller, or more than 50% smaller.For example, the internal volume of the portion of catheter 1210adjacent balloon 1260 is smaller when balloon 1260 is inflated, as shownin FIG. 17B, than when balloon 1260 is deflated, as shown in FIG. 16B.

In some embodiments, an internal shape of the catheter adjacent theballoon may be substantially circular when the balloon is deflated andnon-circular when the balloon is inflated. The internal shape of thecatheter may refer to the form, contour or outline of a cross-section ofthe catheter, defined by the walls of the catheter and optionally theballoon. When the balloon is inflated, the balloon may create aprotuberance into the inner lumen. In at least one example, theseprotuberances may cause the internal shape of the catheter to be anintersection of a first circular shape (the original circular shape ofthe inner lumen) and the area not including in a second circular shape(created by the balloon), where the diameter of the second circularshape may be much larger than the diameter of the first circular shape.When the balloon is deflated, the balloon may be situated outside of theinner lumen, as described in greater detail above, and so may not havean effect on the internal shape of the catheter. For example, theinternal shape of catheter 1210 adjacent balloon 1260 is substantiallycircular when balloon 1260 is deflated, as shown in FIG. 16B, andnon-circular when balloon 1260 is inflated, as shown in FIG. 17B.

In some embodiments, the tube may be arranged over the catheter, with aninflation passage formed between an outer surface of the catheter and aninner surface of the tube for delivery of inflation fluid to theballoon. The tube may be arranged such that it completely or at leastpartially covers or encloses the catheter, defining a space between thetube and the catheter, the inflation passage, configured to deliver aninflation fluid to the balloon. For instance, a tip of the tube may bepositioned outside and/or distal to the catheter. The inflation passagemay be configured to enable a transfer of material from outside thecatheter to and from the balloon. For example, the transferred materialmay be a fluid. For example, the transferred material may be at leastone of a gas and/or a liquid. In at least one example, the balloon maybe configured to inflate in response to a transfer of material to theballoon via the passage, and to deflate in response to a transfer ofmaterial from the balloon via the passage. For example, tube 1230 may bearranged over catheter 1210, as shown in FIGS. 12A-18B, with aninflation passage 1662 formed between the outer surface of catheter 1210and the inner surface of tube 1230 for delivery of inflation fluid toballoon 1260. For instance, balloon 1260 may inflate in response to atransfer of the inflation fluid to balloon 1260 via inflation passage1662, and to deflate in response to a transfer of the inflation fluidfrom balloon 1260 via inflation passage 1662.

In some embodiments, the tube may include an airtight seal on anopposite side of the balloon from the inflation passage, wherein theairtight seal may be configured to secure the catheter and the tubeagainst relative movement. The airtight seal of the tube and/or thecatheter may be a connector joining the tube and the catheter in aconnection that may be impermeable to air or nearly so. In someexamples, the connector may be made of glue. In other examples, theconnector may be made of a metal alloy, such as Nitinol. The airtightseal may be provided on an opposite side of the balloon from theinflation passage, that is, on a distal end of the catheter, asdescribed in greater detail herein. In at least one example, theconnector may connect the tube to a tip of the catheter. In at least oneexample, the connector may connect the tube to an inner wall of thecatheter, for example, at a distal portion of the catheter (such as thelast one inch of the catheter, the last 10 inches of the catheter, orany appropriate distal portion of the catheter). In at least oneexample, the tube may encircle the tip of the catheter and the connectormay connect the tube to an external wall of the catheter. The airtightseal may be affixed such that the tube and the catheter do not moverelative to each other in at least an axial direction. For example, tube1230 may include an airtight seal 1232 on an opposite side of balloon1260 from inflation passage 1662, as shown in FIGS. 16A-18B, whereinairtight seal 1232 may be configured to secure catheter 1210 and tube1230 against relative movement.

In some embodiments, the airtight seal may include an inner surfacedelimiting an interior volume contiguous with the inner lumen of thecatheter, and wherein the inner lumen of the catheter and the interiorvolume of the airtight seal may form a delivery channel for advancementof a medical instrument therethrough. For example, the airtight seal mayhave a cross-section similar to the catheter, and may define an interiorvolume corresponding to the cross-section multiplied by the length ofthe airtight seal. The interior volume may be contiguous with the innerlumen of the catheter, forming a channel between the interior volume ofthe airtight seal and the inner lumen. In some embodiments, the channelmay be a delivery channel for advancement of a medical instrumenttherethrough. Thus, the inner lumen and the interior volume of theairtight seal may form a delivery channel for enabling selectiveadvancement of a medical instrument therethrough, such as anendovascular coil, for example, during use of the endovascular apparatusfor delivery of the medical instrument to a treatment site. As usedherein, selective advancement of the medical instrument may refer to themovement of the medical instrument through the delivery channel beingcontrollable (e.g., by a user of the endovascular apparatus), such thatthe direction, speed, and length of the medical instrument passedthrough the delivery channel may be controlled. For example, selectiveadvancement of the medical instrument may enable proximal, distal, androtational movement of the instrument relative to the endovascularapparatus. Additionally or alternatively, selective advancement mayenable control over the length of the medical instrument that isdelivered from the distal end of the endovascular apparatus (and, thus,the length of the instrument remaining within the delivery channel ofthe endovascular apparatus). For example, airtight seal 1232 may includean inner surface delimiting an interior volume, as shown in FIGS.12A-18B, contiguous with inner lumen 1214 of catheter 1210. Inner lumen1214 and the interior volume of airtight seal 1232 may form a deliverychannel for advancement of a medical instrument 1220 therethrough.

In some embodiments, the balloon may be configured to be selectivelyinflated and deflated based on control signals from a control devicepositioned outside a body of a patient. In some embodiments, a controldevice may be an apparatus which may be configured to selectivelyinflate and/or deflate the balloon by sending control signals to adevice capable of delivering the inflation fluid to the balloon. In someembodiments, the control device may be configured to receive a commandfrom a user input device, such as by a press of a button or key, a turnof a dial, an input through a computer-generated user interface, a voicecommand recognized in captured audio data through a voice recognitionalgorithm, a gesture recognized in captured image data through a gesturerecognition algorithm, or any other action which may be performed by auser. The control unit may then transmit a corresponding control signalto a control component of the balloon to cause the balloon to performthe requested action (e.g., to expand into the inner lumen of thecatheter). The signals from the control device may be transmitted to thecontrol component of the constrictor wirelessly and/or via a wiredconnection. Additionally, or alternatively, the control device mayreceive data, such as from a sensor associated with the endovascularapparatus and/or an imaging device; may generate the control signalbased on the received data; and transmit the control signal to thecontrol component of the balloon For example, the balloon may beconfigured to inflate in response to a first action of a user of theendovascular apparatus, for example, an interventional radiologist, andmay be configured to deflate in response to a second action of the user.For example, when the balloon is in a blood vessel, the user may performa first action such as activating an inflation pump and a second actionsuch as deactivating the inflation pump or operating the pump to removethe inflation fluid from the balloon. The pump and the control devicemay be configured to be positioned outside the body of the patient. Forexample, balloon 1260 may be configured to be selectively inflated anddeflated based on control signals from a control device 1900 of FIG. 19positioned outside a body of a patient. For instance, control device1900 may be configured to receive a command from a user input device1910 or may be configured to receive an input from sensors 1912 orimaging device 1914 allowing control device 1900 to take an action.Control unit 1900 may then transmit a control signal to balloon controlcomponent 1942 to cause balloon 1260 to perform the requested action(e.g., to inflate or deflate).

In some embodiments, the endovascular apparatus may include at least oneadditional balloon affixed to the catheter for expansion into the innerlumen of the catheter when the at least one additional balloon isinflated. The at least one additional balloon may be appended to thecatheter at a position different than the position of the balloon andmay be configured to expand into the inner lumen through a differentopening in the catheter when the at least one additional balloon isinflated. In some embodiments, the balloon and the at least oneadditional balloon may be configured to be inflated simultaneously. Forexample, the balloon and the at least one additional balloon may sharethe same inflation passageway and may be configured to receive theinflation material simultaneously. Alternatively, the balloon and the atleast one additional balloon may have different inflation passagewaysand may be configured to receive the inflation material simultaneouslyor at different times. In one example, the at least one additionalballoon may be configured to inflate inside the catheter after theinflation of the balloon or before the inflation of the balloon. In oneexample, the at least one additional balloon may not be connected to thetube but instead connected to a different tube. In another example, theat least one additional balloon may not be connected to any tube. Forexample, endovascular apparatus 1200 may include at least one additionalballoon, which may be located at the same axial location as balloon 1260or which may be located proximal to or distal to balloon 1260. Where theapparatus includes multiple openings in the catheter 1210, a balloon maybe arranged to cover each of the openings.

In some embodiments, the balloon may be configured to exert a strongerfriction force on a medical instrument within the inner lumen of thecatheter when the balloon is inflated, compared to when the balloon isdeflated. A friction force may refer to a force resisting the relativemotion of solid surfaces sliding against each other, for example, arelative motion of the medical instrument and the catheter or a relativemotion of the medical instrument and the balloon. As an example, whenthe balloon is inflated, the balloon may expand within the inner lumenof the catheter, causing the balloon to come into contact with themedical instrument, in turn exerting a friction force on the medicalinstrument which is larger than the friction force exerted when theballoon is deflated. In another example, inflation of the balloon maycause the catheter to constrict, causing the inner walls of the catheterto exert a greater friction force on the medical instrument than whenthe balloon is deflated. In some embodiments, upon inflation, theballoon may be configured to secure the medical instrument within theinner lumen of the catheter against axial movement. For example, thestronger friction force exerted on the medical instrument due to theinflation of the balloon may inhibit, limit, or resist axial advancementand/or retraction, i.e., inhibit the medical instrument from movingalong the length of the inner lumen catheter. In some embodiments, theballoon may be configured to obstruct axial advancement of the medicalinstrument through the inner lumen of the catheter when the balloon isinflated. For example, the inflation of the balloon may completely or atleast partially block the inner lumen of the catheter, inhibiting axialadvancement of the medical instrument. For example, balloon 1260 may beconfigured to exert a stronger force on medical instrument 1220 withininner lumen 1214 when balloon 1260 is inflated, as in FIG. 17A, comparedto when balloon 1260 is deflated, as in FIG. 16A. In some embodiments,upon inflation, balloon 1260 may be configured to secure medicalinstrument 1220 within inner lumen 1214 of catheter A1210 against axialmovement by clamping medical instrument 1220 at a clamped region 2321,as shown in FIG. 24. In some embodiments, balloon 1260 may be configuredto obstruct axial displacement of medical instrument 1220 through innerlumen 1214 of catheter 1210, inhibiting axial advancement of medicalinstrument 1220, as shown in FIG. 23, where the inflation of balloon1260 causes inner lumen 1214 to be completely or at least partiallyblocked.

In some embodiments, an axial distance between the balloon and a distaltip of the catheter may be equal to one inch or less. The distal tip ofthe catheter may refer to a tip of catheter closest to the distal end ofthe catheter, as described in greater detail herein. The axial distancemay refer to a distance between the distal tip of the catheter and theballoon, which may be ten inches or less, five inches or less, twoinches or less, one inch or less, one centimeter or less, or twomillimeters or less. For example, an axial distance may be defined bythe distance between balloon 1260 and a distal tip 1212 of catheter1210.

In some embodiments, the endovascular apparatus may include at least oneelectrode which may be located at the same axial position along thecatheter as the balloon, wherein upon inflation of the balloon, theballoon may be configured to press a medical instrument within the innerlumen of the catheter against the at least one electrode. As usedherein, an electrode may include an electrical conductor used toselectively make contact with an object and to enable an electricalcurrent to flow from the electrode to the object and/or from the objectto the electrode, as described in further detail herein. The at leastone electrode may be positioned along the catheter at a location nearthe balloon. In some embodiments, the at least one electrode may bewithin the inner lumen of the catheter opposite the balloon. When theballoon is inflated, the balloon may provide enough force so as to pushon the medical instrument being delivered within the inner lumen of thecatheter, causing the medical instrument to come into contact with theelectrode. For example, endovascular apparatus 1200 may include at leastone electrode 1242 which may be located at the same axial position alongcatheter 1210 as balloon 1260, as shown in FIGS. 12A-18B. Upon inflationof balloon 1260, balloon 1260 may be configured to press medicalinstrument 1220 within inner lumen 1214 of catheter 1210 against atleast one electrode 1242, as shown in FIG. 17A, where a coil section1724 comes into contact with at least one electrode 1242.

In some embodiments, the at least one electrode may be connected to anelectrical circuit configured to deliver energy in a quantity sufficientto sever the medical instrument within the inner lumen of the catheterwhen the balloon presses the medical instrument against the at least oneelectrode. As used herein, an electrical circuit may include aninterconnection of electrical components configured to deliver currentvia the electrode in such a way as to separate an endovascularinstrument in two, as described in greater detail herein. In someexample, the quantity sufficient to sever the medical instrument may bea function of the characteristics of the medical instrument, such as amaterial composition of the medical instrument, a structure of themedical instrument, a diameter of the medical instrument, an electricalresistance of the medical instrument, or any other appropriatecharacteristic of the medical instrument. Moreover, in some examples,the quantity sufficient to sever the medical instrument may be afunction of the manner in which the energy is delivered, such as thedistribution of energy delivered over time, or the concentration ofenergy delivered at specific portion of the endovascular instrument. Forexample, provided that the medical instrument is an endovascular coil,for some common endovascular coils, delivering energy of between 10 to300 watt per second for a duration of 0.1 to 10 seconds is typically aquantity sufficient to sever the medical instrument, but other amountsmay be required as described above. For example, at least one electrode1242 may be connected to an electrical circuit 1243, as shown in FIG.14, configured to deliver energy in a quantity sufficient to severmedical instrument 1220 within inner lumen 1214 of catheter 1210 whenballoon 1260 presses medical instrument 1220 against at least oneelectrode 1242, as shown in FIG. 18A.

Various embodiments of the current disclosure include non-transitorycomputer readable media containing instructions for controlling aballoon affixed to a catheter in a body of a patient. Consistent withother disclosed embodiments, computer-readable media may store programinstructions, which are executable by at least one processing device andperform any of the steps and/or methods described herein. Theinstructions for controlling a balloon may correspond to method 2900 ofFIG. 29, and may be performed by, for example, processor 1902 of controldevice 1900 of FIG. 19.

The instructions for controlling a balloon of the current disclosure mayinclude obtaining a first input for inflating the balloon, which mayrefer to instructions for receiving, retrieving, or otherwise acquiringan input which confirms that the balloon is to be inflated. By way ofexample, processor 1902 of FIG. 19 may receive a first input from atleast one of user input device 1910, sensors 1912, or imaging device1914 containing instructions for inflating the balloon. The instructionsfor obtaining a first input for inflating the balloon may correspond tostep 2902 of FIG. 29.

The instructions for controlling a balloon of the current disclosure mayfurther include, in response to the first input, initiating fluid flowthrough a conduit connected to the balloon to cause inflation of theballoon, wherein inflation causes the balloon to expand into an innerlumen of the catheter. By way of example, processor 1902 of FIG. 19 mayinitiate fluid flow through conduit 1662 (also inflation passage 1662)of FIGS. 16A-18B to cause inflation of balloon 1260 by sending a controlsignal to balloon control component 1942, which may include a pump forproviding balloon 1260 with an inflation fluid. This may cause balloon1260 to expand into inner lumen 1214 of catheter 1210, as described ingreater detail herein. The instructions of initiating fluid flow througha conduit connected to the balloon to cause inflation of the balloon maycorrespond to step 2904 of FIG. 29.

The instructions for controlling a balloon of the current disclosure mayfurther include, after causing the inflation of the balloon, obtaining asecond input for deflating the balloon. By way of example, processor1902 of FIG. 19 may obtain a second input from at least one of userinput device 1910, sensors 1912, or imaging device 1914 containinginstructions for deflating the balloon. The instructions for obtaining asecond input for deflating the balloon may correspond to step 2906 ofFIG. 29.

The instructions for controlling a balloon of the current disclosure mayfurther include, in response to the second input, causing deflation ofthe balloon with the conduit, wherein an outer diameter of a portion ofthe catheter adjacent the balloon is substantially the same when theballoon is inflated and when the balloon is deflated. By way of example,processor 1902 of FIG. 19 may cause deflation of balloon 1260 by sendinga control signal to balloon control component 1942 to remove theinflation fluid from conduit 1662. The instructions for causingdeflation of the balloon with the conduit may correspond to step 2908 ofFIG. 29.

The instructions for controlling a balloon of the current disclosure mayfurther include obtaining a medical image of the body of the patientcaptured while the catheter is positioned at least partially within thebody. A medical image of the body of the patient may refer to adepiction of the interior of the body of the patient for clinicalanalysis and medical intervention, as well as visual representation ofthe function of some organs or tissues. The medical image may beobtained while the catheter is provided within the body, for example,during a medical procedure. By way of example, processor 1902 of FIG. 19may obtain a medical image of the body of the patient by sending asignal to imaging device 1914 while catheter 1210 is positioned at leastpartially within the body.

The instructions for controlling a balloon of the current disclosure mayfurther include controlling at least one of the inflation or thedeflation of the balloon based on data derived from the medical image.By way of example, processor 1902 of FIG. 19 may determine whether tosend instructions for inflating or deflating balloon 1260 to ballooncontrol component 1942 based on data derived from an analysis of themedical image. Said analysis may be performed by processor 1902 based oninstructions stored in memory 1904, or by a user of endovascularapparatus 1200, who may review the medical image and provide an inputvia user input device 1910.

Consistent with the disclosed embodiments, controlling the at least oneof the inflation or the deflation of the balloon based on the dataderived from the medical image may include calculating a convolution ofat least part of the medical image, deriving a value of the calculatedconvolution, and selecting a degree of inflation of the balloon based onthe derived value. A one-dimensional convolution may refer to a functionthat transforms an original sequence of numbers to a transformedsequence of numbers, as described in greater detail herein. A value of acalculated one-dimensional convolution may include any value in thetransformed sequence of numbers. An n-dimensional convolution may bedefined by an n-dimensional array as scalars (known as the kernel of then-dimensional convolution), as described in greater detail herein. Eachparticular value in the transformed array may be determined bycalculating a linear combination of values in an n-dimensional region ofthe original array corresponding to the particular value. Deriving avalue of the calculated convolution may include using machine learningor deep learning algorithms to determine the value of the calculatedconvolution. Selecting a degree of inflation of the balloon based on thederived value may refer to determining an appropriate level at which theballoon must be inflated based on the derived value. For example, if thederived value indicates that the endovascular apparatus must inflate theballoon because data derived from the medical image indicates that ananeurysm is completely filled and advancement of an endovascular coilmust be stopped to prevent overfilling, the instructions provide forchoosing an appropriate degree of inflation to inflate the balloon tosecure the endovascular coil, inhibit axial displacement, and optionallysevering the endovascular coil. By way of example, processor 1902 ofFIG. 19 may perform method 3000 of FIG. 30 for controlling the at leastone of the inflation or the deflation of the balloon based on the dataderived from the medical image to calculate a convolution of at leastpart of the medical image, corresponding to step 3002, derive a value ofthe calculated convolution, corresponding to step 3004, and select adegree of inflation of balloon 1260 of FIGS. 17A-18B based on thederived value, corresponding to step 3006.

Aspects of this disclosure may relate to novel non-transitory computerreadable medium instructions for operating a sensor that may monitorwhen medical instrument, e.g., an endovascular coil, may be about to beor may have been completely severed by the delivery catheter and thus,may be detached from the remainder of the coil. In some embodiments, thecoil-cutting electrode may be configured as the sensor. Additionally, oralternatively, the sensor may be configured to detect motion of the coilrelative to the catheter, which may indicate that the coil has beendetached and released from the catheter. Sensor output may be used toalert the physician or an automated process when coil detachment hasfailed. Alternatively, or advantageously, sensor output may be usedbefore the coil detachment attempt to indicate that the conditions maybe unsuitable for coil detachment and an action may be required beforethe coil detachment attempt may be made so that the physician or theautomated process may reposition the coil within the catheter or maycause a narrowing of the catheter before attempting or repeating theattempt of the coil detachment operation. Further, sensor output mayalso be used to control functions of the delivery catheter. For example,sensor output may indicate poor contact between the electrode andmedical instrument and may cause the catheter to execute a function thatmay increase electrode-to-coil contact and then repeat the coildetachment operation. However, the instructions may additionally oralternatively be configured for use with other instrumentation and/orfor other suitable processes.

Various embodiments of the current disclosure may relate tonon-transitory computer readable medium containing instructions formonitoring partitioning of a medical instrument during an endovascularprocedure. As used herein, an endovascular procedure may refer to anyprocedure used on arteries, veins, blood vessels or other similar partsof the body for a medical purpose, for example to diagnose and/or treata patient. As used herein, monitoring may refer to observing, watching,or any other means of checking the progress, status or quality ofpartitioning the medical instrument during the procedure. As usedherein, partitioning may refer to separating, subdividing, splitting, orany other process of dividing the medical instrument into parts. Somenon-limiting examples of endovascular procedures may include aneurysmrepair, peripheral bypass surgery, carotid angioplasty and stenting,carotid endarterectomy, dialysis access surgery, endovascular repair,stent graft delivery, thromboendarterectomy, thrombolytic therapy,varicose vein treatment or other minimally invasive catheter techniqueprocedures. For example, the user (e.g., a doctor) may monitor thepartitioning of a medical instrument during an aneurysm repair surgeryor a similar medical instrument during an endovascular procedure.

FIG. 31 depicts instructions for monitoring partitioning 3100 of amedical instrument 1220 (e.g., an endovascular coil) during anendovascular procedure as shown in FIGS. 22A-22F.

Consistent with disclosed embodiments, the medical instrument mayinclude an endovascular coil configured for delivery through the lumenof the catheter. As discussed herein, an endovascular coil may bedefined herein

FIGS. 12A and 12B depict a medical instrument 1220 (e.g., anendovascular coil) configured for delivery through a lumen 1214 (e.g.,an inner lumen) of a catheter 1210 (e.g., a microcatheter).

Consistent with disclosed embodiments, the operations may includeobtaining an input to activate a partitioning mechanism associated witha medical instrument within a lumen of a catheter, the catheter beingpositioned within a body. In some examples, an input to activate apartitioning mechanism may be obtained. As used herein, obtain may referto getting, acquiring, coming by, procuring or any other means ofsecuring something. As used herein, activate may refer to switching on,turning on, starting, triggering or any other means to make somethingoperative. In some examples, the input may be indicative of a desire ofan interventional radiologist to activate the partitioning mechanism.For example, the interventional radiologist may perform an actionindicative of the desire to activate the partitioning mechanism (such aspressing a button, sliding a slider, turning a dial, entering data in auser interface, touching a touch sensitive sensor, audibly providing avoice command, and so forth), and the input may be a result of theaction. In some examples, the input may be indicative of an automatedsystem determining a need to activate the partitioning mechanism. Forexample, a medical image of the medical instrument within the lumen ofthe catheter positioned within the body may be received, and the medicalimage may be analyzed to determine the need to activate the partitioningmechanism. In another example, sensor readings from one or more sensorsaffixed to the catheter may be received, and the sensor readings may beanalyzed to determine the need to activate the partitioning mechanism.In one example, the input may include at least one of a digital signalreceived from an external device, a signal received from a sensor, anddata read from memory. As used herein, a partitioning mechanism mayinclude any device configured to sever a medical instrument (such as oneincluding an endovascular coil). In some examples, the partitioningmechanism may be affixed to a catheter, for example to an internal wallof the catheter, to an external wall of the catheter, to a distal tip ofthe catheter, to a distal portion of the catheter (such as the last oneinch of the catheter, the last ten inches, etc.), and so forth. In someexamples, the partitioning mechanism may be configured to sever themedical instrument while in a body of a patient. Some non-limitingexamples of a partitioning mechanism may include one or more electrodesconfigured to cause flow of an electrical current through a portion ofthe medical instrument, a device including a sharp edge configured tosever the medical instrument by applying force focused on a particularregion of the medical instrument, a looped wire configured to tighteningaround the medical instrument to sever it, a heat source configured toheat a portion of the medical instrument to sever it, and so forth.

FIG. 31 depicts an example of instructions for monitoring partitioning3100 with the operations including obtaining an input (step 3102) toactivate a partitioning mechanism (step 3104) associated with a medicalinstrument 1220 (e.g., an endovascular coil) within a lumen 1214 (e.g.,an inner lumen) of a catheter 1210 (e.g., a microcatheter), the catheterbeing positioned within a body. FIG. 19 depicts a non-transitorycomputer readable medium with different inputs including an imagingdevice 1914. For example, a medical image of the medical instrument 1220(e.g., endovascular coil) within the inner lumen 1214 of the catheter1210 positioned within the body may be received, and the medical imagemay be analyzed to determine the need to activate the partitioningmechanism by step 3104. FIG. 19 also depicts a sensor or sensors input1912. For example, the sensor readings may be analyzed to determine theneed to activate the partitioning mechanism by step 3104. FIGS. 12A and12B may depict an example of a partitioning mechanism which may includeat least one electrode 1242 configured to cause flow of an electricalcurrent through a portion of the medical instrument 1220.

Consistent with disclosed embodiments, the partitioning mechanism may belocated at least partially within the lumen of the catheter. As usedherein, partially may refer to partly, somewhat, or to a limited extent.For example, the partitioning mechanism can be partially a quarter,half, three quarters, or any other measurement within a lumen of acatheter. In some examples, part of the partitioning mechanism may beaffixed to an internal wall of the catheter and the other part of thepartitioning mechanism may be affixed to an external wall of thecatheter, and so forth.

FIGS. 12A and 12B depict a partitioning mechanism with an at least oneelectrode 1242 that may be affixed to an internal wall 1211 (e.g., aninner wall of a sheath) within the inner lumen 1214 of a catheter 1210(e.g., microcatheter).

Consistent with disclosed embodiments, the operations may include inresponse to the input, activating the partitioning mechanism. As usedherein, response may refer to feedback, a reply, a return, anacknowledgment or any other reaction to something or the input. Forexample, the operations may provide feedback or a reply to the input(such as pressing a button, sliding a slider, turning a dial, enteringdata in a user interface, touching a touch sensitive sensor, audiblyproviding a voice command, and so forth) to activate the partitioningmechanism. In an example, the input may include at least one of adigital signal received from an external device, a signal received froma sensor, and data read from memory. Advantageously, some embodimentsmay be configured wherein activating the partitioning mechanism mayinclude at least one electrode in a catheter to delivery energy to anadjacent portion of a medical instrument. As used herein, deliver energymay refer to bringing, taking, conveying, carrying or any other means ofproviding energy, power, activity, force or any other property to a siteto perform work on the site or heat it. For example, energy may exist inpotential, kinetic, thermal, helictical, chemical, nuclear, electric orother forms. In some embodiments, the at least one electrode or morethan one electrode may deliver energy in the form of electricity to acatheter next to the at least one electrode, across from the at leastone electrode, distal to the at least one electrode, or proximal to theat least one electrode. Alternatively, the at least one electrode ormore than one electrode may deliver thermal energy to the catheter nextto the at least one electrode, across from the at least one electrode,distal to the at least one electrode, or proximal to the at least oneelectrode.

FIG. 31 depicts instructions for monitoring partitioning 3100 with theoperations including activating the partitioning mechanism (step 3104)in response to the input obtained by step 3102. FIGS. 12A and 12B depictan embodiment wherein activating the partitioning mechanism by step 3104may include an at least one electrode 1242 in a catheter 1210 (e.g., amicrocatheter) to deliver energy to an adjacent portion of a medicalinstrument 1220 (e.g., an endovascular coil). FIG. 17A depicts anexample of the adjacent portion of the medical instrument 1220 as a coilsection in contact with the least one electrode 1242 for energy to bedelivered.

Consistent with disclosed embodiments, activating the partitioningmechanism in response to the input may include: (i) determining whetherthe medical instrument is in a partitioning readiness state, (ii) if thepartitioning readiness state of the medical instrument may be detected,activating the partitioning mechanism to sever the medical instrument,and/or (iii) if the partitioning readiness state of the medicalinstrument is not detected, outputting a second instruction toreposition the medical instrument relative to the partitioning mechanismand re-determining whether the medical instrument is in the partitioningreadiness state. As used herein, a partitioning readiness state mayrefer to the medical instrument's shape, situation, position, particularcondition, or state of being prepared to be partitioned at a specifictime. For example, sensors or a medical image of the medical instrument(e.g., an endovascular coil) may be used to determine whether themedical instrument may be in a specific position relative to thepartitioning mechanism to be partitioned. Advantageously, someembodiments may be configured to activate the partitioning mechanism tosever the medical instrument by inducing an electric current from the atleast one electrode through the medical instrument if the partitioningreadiness state of the medical instrument is detected. Alternatively,embodiments may be configured to output a second instruction toreposition the medical instrument relative to the partitioning mechanismand re-determine whether the medical instrument is in the partitioningreadiness state if the partitioning readiness state of the medicalinstrument is not detected. As used herein, an instruction may refer toan order, command, directive, dictation, demand, or other detailedinformation telling how something should be done. As used herein,reposition may refer to moving, shifting, relocating or placing in adifferent position before the next activation of the partitioningmechanism. For example, if the partitioning readiness state of themedical instrument is not detected, the second instruction may beoutputted to instruct the user to reposition the medical instrumentforward, backward, to one side, or to the other side relative to thepartitioning mechanism and then re-determining whether the medicalinstrument is in the partitioning readiness state.

FIG. 32 depicts instructions for activating the partitioning mechanismby step 3104, for example in response to the input received by step3102. Embodiments may be configured to include determining whether amedical instrument 1220 (e.g., an endovascular coil) is in apartitioning readiness state (step 3206). Further, if the partitioningreadiness state of medical instrument 1220 is detected (case 3102), thenthe instructions may activate the partitioning mechanism in response toinput (for example, as described in relation to step 3104).Alternatively, if the partitioning readiness state is not detected (case3104), then the instructions may output a second instruction toreposition the medical instrument 1220 relative to the partitioningmechanism (step 3210), and may further re-determine whether medicalinstrument 1220 is in the partitioning readiness state after therepositioning, for example using step 3206. For example, if thepartitioning readiness state is detected (case 3212), the secondinstruction may be outputted to instruct the user to reposition theendovascular coil (step 3210), for example forward, backward, to oneside, and/or to the other side relative to the partitioning mechanism,and may further re-determining whether medical instrument 1220 is in thepartitioning readiness state after the repositioning, for example using3206.

Consistent with disclosed embodiments, the partitioning readiness stateof the medical instrument may be determined based on at least one of (i)a position of the medical instrument relative to the partitioningmechanism, (ii) a degree of contact between the partitioning mechanismand the medical instrument, (iii) a flow of electric current from thepartitioning mechanism through the medical instrument, or (iv) anelectrical impedance of an electrical circuit including the partitioningmechanism and the medical instrument. As used herein, a degree ofcontact may refer to an amount, extent or point of a union or junctionof surfaces between the electrode and the medical instrument (e.g., anendovascular coil). For example, the partitioning readiness state may bedetermine based on where the medical instrument is located relative tothe partitioning mechanism (e.g., parallel with, close to, far from). Inan example, a degree of contact may be a measure of at least one ofelectrical conductivity, electrical resistance, electrical capacity andelectrical impedance between the medical instrument and the partitioningmechanism. In another example, a degree of contact may be based on anarea of contact region between the medical instrument and thepartitioning mechanism. Non-limiting examples may include a degree ofcontact in the shape of a narrow rectangle between two parallelcylinders or a circular degree of contact between two spheres. Forexample, the degree of contact may be closer to 90° where the electrodeand medical instrument may not be exactly flush with each other.Advantageously, or alternatively the degree of contact may be 180° wherethe electrode and medical instrument may be flush against each other. Inyet another example, a degree of contact may be based on contactpressure between the medical instrument and the partitioning mechanism.Some non-limiting examples may include the degree of contact measuredbetween the medical instrument (e.g., an endovascular coil) and thepartitioning mechanism affixed to a catheter, for example to an internalwall of the catheter, to an external wall of the catheter, to a distaltip of the catheter, to a distal portion of the catheter (such as thelast one inch of the catheter, the last ten inches, etc.), and so forth.Further, the degree of contact may include the degree of contactmeasured between one or more electrodes configured to cause flow of anelectrical current through a portion of the medical instrument, thedegree between a device including a sharp edge configured to sever themedical instrument by applying force focused on a particular region ofthe medical instrument, the degree between a looped wire configured totightening around the medical instrument to sever it, the degree betweena heat source configured to heat a portion of the medical instrument tosever it, and so forth.

FIG. 33 depicts instructions for determining the partitioning readinessstate of a medical instrument 1220 (e.g., an endovascular coil) by step3206 based on at least one of (i) a position of the medical instrumentrelative to the partitioning mechanism (step 3302), (ii) a degree ofcontact between the partitioning mechanism and the medical instrument(step 3304), (iii) a flow of electric current from the partitioningmechanism through the medical instrument (step 3306), or (iv) anelectrical impedance of an electrical circuit including the partitioningmechanism and the medical instrument (step 3308). FIG. 17A may depict adegree of contact of 180° between the at least one electrode 1242 and amedical instrument 1220 flush against each other where a coil section1724 may be in contact with the at least one electrode.

Consistent with disclosed embodiments, the partitioning readiness stateof the medical instrument may be determined based on at least a flow ofelectric current from the partitioning mechanism through the medicalinstrument. For example, the partitioning readiness state may indicatewhether electrical current flowed from the electrode through the medicalinstrument (e.g., an endovascular coil). Alternatively, or additionally,the partitioning readiness state may indicate whether electrical currentdid not flow from the electrode through the medical instrument. Further,the partitioning readiness state may indicate how much or how littleelectrical current flowed from the electrode through the medicalinstrument.

FIG. 33 depicts instructions for determining the partitioning readinessstate of a medical instrument 1220 (e.g., an endovascular coil) by step3206 based on at least a flow of electric current from the partitioningmechanism through the endovascular coil (step 3306).

Consistent with disclosed embodiments, the partitioning readiness stateof the medical instrument may be determined based on at least anelectrical impedance of an electrical circuit including the partitioningmechanism and the medical instrument. As used herein, electricalimpedance may refer to electrical resistance, ohms, resistance,resistivity, ohmic resistance, ohmage or any other amount of oppositionto the electrical current. As used herein, an electrical circuit mayrefer to a course, route, wiring, bridge or any other closed path inwhich electrons move to produce electric current. For example, thepartitioning readiness state may indicate the electrical impedance orresistance of the electrical circuit including the electrode and themedical device (e.g., an endovascular coil) or multiple electrodes andmultiple medical devices. Alternatively, the partitioning readinessstate may indicate a lower electrical impedance or resistance of theelectrical circuit indicating that the flow of electricity easily flows.Or some embodiments may be configured where the partitioning readinessstate indicates a higher electrical impedance or resistance of theelectrical circuit indicating that the flow of electricity does noteasily flow. Advantageously, the partitioning readiness state mayindicate the degree of contact, the flow of electrical current, and theelectrical impedance in relation to the electrode and the medicalinstrument.

FIG. 33 depicts instructions for determining the partitioning readinessstate of a medical instrument 1220 (e.g., an endovascular coil) by step3206 based on at least an electrical impedance of an electrical circuitincluding the partitioning mechanism and the endovascular coil (step3308).

Consistent with disclosed embodiments, activating the partitioningmechanism may include selecting a quantity of energy for delivery by thepartitioning mechanism. As used herein, selecting may refer to picking,limiting, electing, choosing, preferring or any other method of choosingsomething. As used herein, a quantity of energy may refer to a sum,mass, weight, volume, load or any other amount or number of energy. Forexample, a selection of the quantity of energy may be one, less thanone, or more than one watt, kilowatt, joule, calorie, erg,kilowatt-hour, BTU, and so forth. Advantageously, the quantity may beselected based on a structural property of the medical instrument. Asused herein, structural property may refer to an anatomical,architectural, skeletal, assembled, form, make, manufacture or any otherarrangement of parts that gives property its basic form. For example, asmaller quantity of energy, like a milliwatt or picowatt, may be chosenbased on the medical instrument being a microcatheter. Alternatively, alarger quantity of energy, like a centiwatt or deciwatt, may be chosenbased on the medical instrument being a catheter. Alternatively, oradditionally, activating the partitioning mechanism may includecontrolling the partitioning mechanism for delivery of the selectedquantity of energy. As used herein, control may refer to regulating,restraining, restricting, limiting, subjecting, manipulating orotherwise influencing. In some embodiments, activating the partitioningmechanism may include both selecting a quantity of energy andcontrolling the partitioning mechanism for delivery of the selectedquantity of energy. Embodiments may be configured to select a smallerquantity of energy and then may advance the partitioning mechanism arelatively shorter distance than other embodiments that may beconfigured to select a larger quantity of energy and then may advancethe partitioning mechanism a relatively larger distance. Another examplemay be an embodiment configured to retract or restrict the partitioningmechanism if the selected quantity of energy does not reach a thresholdvalue. Other examples of embodiments may be configured to extend oradvance the partitioning mechanism if the selected quantity of energydoes reach a threshold value.

FIG. 32 depicts instructions for activating the partitioning mechanismby step 3104, for example in response to the input obtained by step3102. In some embodiments, activating the partitioning mechanism mayinclude selecting a quantity of energy for delivery by the partitioningmechanism (step 3202). Advantageously, in step 3204, the quantity ofenergy for delivery selected may be based on a structural property ofthe medical instrument 1220 (e.g., an endovascular coil).

Consistent with disclosed embodiments, the operations may includefollowing the activation, obtaining partitioning outcome data. In someexamples, partitioning outcome data may include data indicative ofwhether the medical instrument was successfully severed. In otherexamples, partitioning outcome data may include data indicative ofwhether the medical instrument was not successfully severed. Consistentwith disclosed embodiments, obtaining the partitioning outcome data mayinclude obtaining a medical image of at least a portion of the bodywhile the catheter may be positioned within the body. For example, themedical image may provide an image of the aneurysm, an image of theaneurysm and catheter, an image of the catheter, or a similar imagewithin the body near a treatment site to provide data and/or be analyzedwhether the medical instrument was successfully severed and/or whetherthe medical instrument may be in a position that enables thepartitioning mechanism to sever it. Advantageously, in some embodiments,obtaining the partitioning outcome data may include determining thepartitioning outcome data based at least partially on the medical image.For example, the medical image may partially be used in conjunction withother variables, sensors, inputs, or outputs to determine thepartitioning outcome data. In one example, the medical image of theaneurysm and catheter may provide data or be analyzed in conjunctionwith a contact, motion, or pressure sensor within a lumen of thecatheter to determine the partitioning outcome data. In another example,a convolution of at least part of the medical image may be calculated toderive at least one output value of the calculated convolution. Further,in response to a first output value of the calculated convolution, itmay be determined that the medical instrument is in a severed state,while in response to a second output value of the calculatedconvolution, it may be determined that the medical instrument is inconnected state. In yet another example, the medical image may beanalyzed to detect (for example, using object detection algorithms) thepartitioning mechanism, as well as the medical instrument from bothsides of the partitioning mechanism. Further, the medical image may beanalyzed to determine whether the portion of the medical instrument fromone side of the partitioning mechanism is connected to the portion ofthe medical instrument from the other side of the partitioning mechanism(for example, using crack detection algorithms) to determine whether themedical instrument is in a connected state (for example, when no crackis detected, when it is determined that the two portions are connected,etc.) or in a severed state (for example, when a crack is detected, whenit is determined that the two portions are not connected, etc.).

FIG. 31 depicts instructions for monitoring partitioning 3100 of amedical instrument 1220 (e.g., an endovascular coil) during anendovascular procedure as shown in FIGS. 22A-22F. Some embodiments mayinclude obtaining partitioning outcome data (step 3106) following theactivation by step 3104. Further, in FIG. 34, obtaining partitioningoutcome data by step 3106 may include obtaining a medical image of atleast a portion of the body while a catheter 1210 (e.g., amicrocatheter) may be positioned within the body (step 3402).

Consistent with disclosed embodiments, obtaining the partitioningoutcome data may include receiving output from at least one sensor. Asused herein, output may refer to a product, thing, object, consequenceor any other place where information leaves a system. As used herein,sensor may refer to a detector, a sensing element or any device thatreceives a signal or stimulus and responds to it in a distinctivemanner. Non-limiting examples of outputs may be visual, data, print, orsound forms. Non-limiting examples of sensors may include ones based ontemperature, proximity, infrared, pressure, light, ultrasonic, and soforth. Advantageously, embodiments may be configured to obtainpartitioning outcome data including output from at least one proximitysensor, from at least one proximity sensor and at least one pressuresensor, or from at least one proximity, at least one pressure sensor,and/or one temperature sensor. In some examples, the partitioningoutcome data may include or be based on data captured using the at leastone sensor affixed to a catheter, for example to an internal wall of thecatheter, to an external wall of the catheter, to a distal tip of thecatheter, to a distal portion of the catheter (such as the last one inchof the catheter, the last ten inches, etc.), to a portion of thecatheter position in the body, and so forth. Embodiments may beconfigured wherein the at least one sensor may be situated within thelumen of the catheter in a distal region thereof. For example, the atleast one sensor may be positioned within the center of the lumen of thecatheter in the distal region. Alternatively, and advantageously, the atleast one sensor may be positioned along an inner wall of the lumen ofthe catheter in the distal region. In other embodiments, two or moresensors may be positioned within the lumen next to each other or acrossfrom each other in the distal region.

FIG. 34 depicts instructions for obtaining partitioning outcome data bystep 3106 following the activation by step 3104. In some embodiments,obtaining the partitioning outcome data in step 3106 may includereceiving output from at least one sensor (step 3404). Further, the atleast one sensor may be situated within a lumen 1214 (e.g., an innerlumen) of a catheter 1210 (e.g., a microcatheter) in a distal regionthereof (case 3406).

Consistent with disclosed embodiments, the at least one sensor mayinclude at least one of a contact sensor, a pressure sensor, or a motionsensor. As used herein, a contact sensor may refer to a sensor wherethere may be a union or junction of surfaces between the sensor andanother object. For example, the at least one sensor may include atleast one contact sensor, and the partitioning outcome data may includedata indicative of a contact of a medical instrument with a particularregion of a catheter or with an element affixed to the catheter (such asan element of the partitioning mechanism, the at least one sensoraffixed to the catheter, etc.). In one example, the contact sensor maybe positioned in the internal wall or lumen of the catheter distal tothe partitioning mechanism. In one example, in a severed state, after adistal portion of the medical instrument is detached from the remainingportion of the medical instrument, the distal portion may be pulledand/or pushed out of the catheter. As a result, the distal portion ofthe medical instrument, which may be in contact with the contact sensorwhen the medical instrument is in a connected state, may be pulledand/or pushed away of the contact sensor when the medical instrument isin a severed state. The contact sensor may determine whether the distalportion of the medical instrument is in contact with the contact sensor.In response to a determination that the distal portion of the medicalinstrument is in contact with the contact sensor, a connected state maybe detected, while in response to a determination that the distalportion of the medical instrument is not in contact with the contactsensor, a severed state may be detected. As used herein, a pressuresensor may refer to a sensor where there may be a coercion, force,pressing, pushing, squeezing or other continuous physical force exertedon or against the sensor by something in contact with it. For example,the at least one sensor may include a pressure sensor in the form of avibration sensor which may capture data associated with vibrations ofthe catheter and/or the medical instrument, and the data may be analyzedto identify vibration patterns associated with a contact of the medicalinstrument with the partitioning mechanism and/or associated with asuccessful activation of the partitioning mechanism that severs themedical instrument and/or associated with a failure of the partitioningmechanism to sever the medical instrument. In one example, the pressuresensor may be positioned in the internal wall or lumen of the catheterdistal to the partitioning mechanism. In one example, in a severedstate, after a distal portion of the medical instrument is detached fromthe remaining portion of the medical instrument, the distal portion maybe pulled and/or pushed out of the catheter. As a result, the distalportion of the medical instrument, which may apply pressure on thepressure sensor when the medical instrument is in a connected state, maybe pulled and/or pushed away of the pressure sensor when the medicalinstrument is in a severed state. The pressure sensor may determinewhether the distal portion of the medical instrument is applyingpressure on the pressure sensor. In response to a determination that thedistal portion of the medical instrument is applying pressure on thepressure sensor, a connected state may be detected, while in response toa determination that the distal portion of the medical instrument is notapplying pressure on the pressure sensor, a severed state may bedetected. As used herein, a motion sensor may refer to a movement,shifting or other change in position of an object relative to thesensor. For example, embodiments with the motion sensor may beconfigured to detect when the medical instrument extends past thelocation of the motion sensor in obtaining partitioning outcome data.The motion sensor may provide data of the position, length, and amountof the medical instrument extending through to the treatment site. Inone example, the motion sensor may be positioned in the internal wall orlumen of the catheter distal to the partitioning mechanism. In oneexample, in a severed state, after a distal portion of the medicalinstrument is detached from the remaining portion of the medicalinstrument, the distal portion may be pulled and/or pushed out of thecatheter. As a result, the distal portion of the medical instrumentmoves, a movement that may be detected by the movement sensor. Inresponse to a detected axial motion of the distal portion (or axialmotion greater than a selected threshold) of the medical instrument, asevered state may be detected, while in response to no axial motion ofthe distal portion (or axial motion smaller than the selectedthreshold), a connected state may be detected. Advantageously, oradditionally, the at least one sensor may include one, two, multiple, orany other combination of sensors (for example, one contact sensor, onepressure sensor, and/or one motion sensor).

FIG. 34 depicts instructions for obtaining partitioning outcome data bystep 3106 following the activation by step 3104. Some embodiments may beconfigured where the at least one sensor may include at least one of acontact sensor (case 3408), a pressure sensor (case 3410), or a motionsensor (case 3412).

Consistent with disclosed embodiments, the at least one sensor mayinclude an electrode associated with the partitioning mechanism, theelectrode being configured to deliver energy for severing the medicalinstrument. For example, the at least one sensor may include at leastone electrode affixed to the catheter, and the partitioning outcome datamay include electromagnetic data (for example, indicative of a flow ofelectrical current through the medical instrument, indicative of atleast one of a flow of electrical current, an electrical resistance, anelectrical capacitance and an electrical impedance between a firstelectrode and a second element, and so forth). Advantageously, the atleast one sensor with an electrode may be used as part of thepartitioning mechanism to deliver energy to sever the medicalinstrument. Embodiments may be configured to deliver energy from theelectrode directly to the medical instrument to sever. Alternatively,embodiments may be configured to deliver energy from one electrode to asecond electrode across the medical instrument to sever.

FIG. 34 depicts instructions for obtaining partitioning outcome data bystep 3106 following the activation by step 3104. In some embodiments,the at least one sensor may include an at least one electrode 1242associated with the partitioning mechanism, the at least one electrode1242 being configured to deliver energy for severing a medicalinstrument 1220 (e.g., an endovascular coil).

Consistent with disclosed embodiments, the partitioning outcome data mayindicate at least one of (i) a degree of contact between the electrodeand the medical instrument, (ii) a flow of electrical current from theelectrode through the medical instrument, or (iii) an electricalimpedance of an electrical circuit including the electrode and themedical instrument. Further, some embodiments may be configured whereinthe partitioning outcome data may be indicative of a degree of contactbetween the medical instrument and the partitioning mechanism. In oneexample, a degree of contact may be a measure of at least one ofelectrical conductivity, electrical resistance, electrical capacity andelectrical impedance between the medical instrument and the partitioningmechanism. In another example, a degree of contact may be based on anarea of contact region between the medical instrument and thepartitioning mechanism. Non-limiting examples may include a degree ofcontact in the shape of a narrow rectangle between two parallelcylinders or a circular degree of contact between two spheres. Forexample, the degree of contact may be closer to 90° where the electrodeand medical instrument may not be exactly flush with each other.Advantageously, or alternatively the degree of contact may be 180° wherethe electrode and medical instrument may be flush against each other.Embodiments may also be configured where the degree of contact refers tothe degree between the medical instrument and the partitioningmechanism. In yet another example, a degree of contact may be based oncontact pressure between the medical instrument and the partitioningmechanism. Some non-limiting examples may include the degree of contactmeasured between the medical instrument (e.g., an endovascular coil) andthe partitioning mechanism affixed to a catheter, for example to aninternal wall of the catheter, to an external wall of the catheter, to adistal tip of the catheter, to a distal portion of the catheter (such asthe last one inch of the catheter, the last ten inches, etc.), and soforth. Further, the degree of contact may include the degree of contactmeasured between one or more electrodes configured to cause flow of anelectrical current through a portion of the medical instrument, thedegree between a device including a sharp edge configured to sever themedical instrument by applying force focused on a particular region ofthe medical instrument, the degree between a looped wire configured totightening around the medical instrument to sever it, the degree betweena heat source configured to heat a portion of the medical instrument tosever it, and so forth.

FIG. 35 depicts instructions for obtaining partitioning outcome data bystep 3106 following the activation by step 3104. In some embodiments,the partitioning outcome data may indicate at least one of (i) a degreeof contact between the at least one electrode 1242 and the medicalinstrument 1220 (e.g., an endovascular coil) (case 3502), (ii) a flow ofelectric current from the at least one electrode 1242 through theendovascular coil (case 3504), or (iii) an electrical impedance of anelectrical circuit including the at least one electrode 1242 and theendovascular coil (case 3506).

Consistent with disclosed embodiments, the partitioning outcome data mayindicate at least a flow of electrical current from the electrodethrough the medical instrument. As used herein, flow may be definedabove. For example, the partitioning outcome data may indicate whetherelectrical current flew from the electrode through the medicalinstrument (e.g., an endovascular coil). Alternatively, or additionally,the partitioning outcome data may indicate whether electrical currentdid not flow from the electrode through the medical instrument. Further,the partitioning outcome data may indicate how much or how littleelectrical current flew from the electrode through the medicalinstrument.

FIG. 35 depicts instructions for obtaining partitioning outcome data bystep 3106 following the activation by step 3104. In some embodiments,the partitioning outcome data may indicate at least a flow of electriccurrent from the at least one electrode 1242 through the medicalinstrument 1220 (e.g., an endovascular coil) (case 3504).

Consistent with disclosed embodiments, the partitioning outcome data mayinclude an electrical impedance of an electrical circuit including theelectrode and the medical instrument. As used herein, electricalimpedance may refer to electrical resistance, ohms, resistance,resistivity, ohmic resistance, ohmage or any other amount of oppositionto the electrical current. As used herein, an electrical circuit mayrefer to a course, route, wiring, bridge or any other closed path inwhich electrons move to produce electric current. For example, thepartitioning outcome data may include the electrical impedance orresistance of the electrical circuit including the electrode and themedical device or multiple electrodes and multiple medical devices.Alternatively, the partitioning outcome data may include a lowerelectrical impedance or resistance of the electrical circuit indicatingthat the flow of electricity easily flows. Or some embodiments may beconfigured where the partitioning outcome data includes a higherelectrical impedance or resistance of the electrical circuit indicatingthat the flow of electricity does not easily flow. Consistent withdisclosed embodiments, the partitioning outcome data may indicate (i) adegree of contact between the electrode and the medical instrument, (ii)a flow of electrical current from the electrode through the medicalinstrument, and/or (iii) an electrical impedance of an electricalcircuit including the electrode and the medical instrument.Advantageously, the partitioning outcome data may include the degree ofcontact, the flow of electrical current, and the electrical impedance inrelation to the electrode and the medical instrument.

FIG. 35 depicts instructions for obtaining partitioning outcome data bystep 3106 following the activation by step 3104. Some embodiments may beconfigured where the partitioning outcome data may include an electricalimpedance of an electrical circuit including the at least one electrode1242 and the medical instrument 1220 (e.g., an endovascular coil) (case3506).

Consistent with disclosed embodiments, the operations may includedetermining, based on the partitioning outcome data, whether the medicalinstrument may be in a severed state or a connected state. As usedherein, connected may refer to attached, linked, secured, fixed, orassociated or related in some respect. Some non-limiting examples of asevered state may include the medical instrument (e.g., an endovascularcoil) in two or more individual pieces. Some non-limiting examples ofconnected may include the medical instrument not broken in two or moreindividual pieces. For example, some embodiments may be configured toinclude partitioning outcome data, which may include a medical image(such as x-ray or CT image) of the medical instrument (e.g.,endovascular coil), to indicate whether the medical instrument may beconnected after an unsuccessful sever attempt or severed after asuccessful sever attempt.

FIG. 31 depicts instructions which may include, in step 3108,determining, based on the partitioning outcome data obtained by step3106, whether the medical instrument 1220 (e.g., an endovascular coil)may be in a severed state (case 3110) or a connected state (case 3114).FIG. 16A depicts the endovascular device 1200 with a medical instrument1220 in the connected state. FIG. 18A depicts the endovascular device1200 with a medical instrument 1220 in the severed state with a severedcoil end 1826 a and a remaining coil section 1828.

Consistent with disclosed embodiments, determining whether the medicalinstrument is in a severed state or a connected state may include (i)calculating, based on the partitioning outcome data, a quantity ofenergy delivered to the medical instrument, (ii) comparing thecalculated quantity of delivered energy to a threshold, and (iii) basedon a result of the comparison, determining whether the medicalinstrument is fully severed. As used herein, calculating may refer tocomputing, figuring, quantifying or any other means of determining theamount or number of something mathematically. For example, based on thepartitioning outcome data (e.g., a medical image of an endovascular coiland/or outputs from various sensors monitoring an endovascular coil),the quantity of energy (e.g., may be one, less than one, or more thanone watt, kilowatt, joule, picowatt) may be calculated to deliver to theendovascular coil. As used herein, threshold may refer to a point,lower-limit, level, the-limit, upper-limit or any other starting pointfor a new state or experience. Advantageously, the threshold may bebased, at least in part, on a structural property of the medicalinstrument. For example, a smaller quantity of energy, like a milliwattor picowatt, may be chosen for the threshold based on the medicalinstrument being a microcatheter. Alternatively, a larger quantity ofenergy, like a centiwatt or deciwatt, may be chosen for the thresholdbased on the medical instrument being a catheter. Some non-limitingexamples may include a threshold of one or less than one, two or lessthan two, three or less than three picowatts, and so forth.Advantageously, the threshold value may be compared to the calculatedquantity of delivered energy to determine if the calculated quantity ofenergy delivered is greater or less than the threshold value. Further,the comparison may be used to determine whether the medical instrumentmay be partially, fully, or not severed. For example, the thresholdlevel may be five picowatts and the calculated quantity of energy may betwo picowatts, thus indicating the threshold level was not met and thusthe medical instrument is not severed. In another example, the thresholdlevel may be five picowatts and the calculated quantity of energy may befour picowatts, thus indicating the threshold level was not met and thusthe medical instrument was partially severed. In another example, thethreshold level may be five picowatts and the calculated quantity ofenergy may be seven picowatts, thus indicating the threshold level wasmet and thus the medical instrument was fully severed.

FIG. 36 depicts instructions where embodiments may be configured wheredetermining whether a medical instrument 1220 (e.g., an endovascularcoil) is in a severed state or a connected state (step 3108) may include(i) calculating, based on the partitioning outcome data, a quantity ofenergy delivered to the endovascular coil 1220 (step 3602), (ii)comparing the calculated quantity of delivered energy to a threshold(step 3604), and (iii) based on a result of the comparison, determiningwhether the medical instrument 12160 is fully severed (step 3606).Advantageously, the threshold may be based, at least in part, on astructural property of the medical instrument (case 3608). For example,a smaller quantity of energy, like a milliwatt or picowatt, may bechosen for the threshold based on the medical instrument 1220 being anendovascular coil. Alternatively, a larger quantity of energy, like acentiwatt or deciwatt, may be chosen for the threshold based on themedical instrument 1220 being something other than an endovascular coil.

Consistent with disclosed embodiments, the operations may include, ifthe severed state of the medical instrument is detected, outputting asuccess notification. As used herein, detect may refer to finding,identifying, recognizing or any other means of discerning. As usedherein, a success notification may refer to proclaiming, warning,alerting, communicating, declaring, informing, messaging or any otheraction of notifying someone or something that an aim or purpose ofsevering has been accomplished or achieved. In some examples, successnotification may include a digital signal transmitted to an externaldevice, may include storage of a success indicator at a predeterminedlocation in a memory device, may include an audible notification, mayinclude a visual notification, may include a notification provided to auser (for example, audibly, visually, through a user interface, etc.),and so forth. Some non-limiting examples of success notifications mayinclude a blinking light-emitting diode (LED), an LED turning andstaying on, an LED turning off, a graphical interface displaying acheck, thumbs-up, or smiley face icon, a message stating “SUCCESS,”“SUCCESSFUL,” or “SUCCESSFUL OPERATION,” a sound (e.g., a ping noise),haptic feedback to the user, and so forth. For example, if the severedstate of the medical instrument (e.g., an endovascular coil) isdetected, an LED may start blinking or turn on to indicate theendovascular coil was severed. Embodiments may be configured to make asound or use haptic feedback if the severed state of the medicalinstrument is detected.

FIG. 31 depicts instructions for monitoring partitioning 3100 of amedical instrument 1220 (e.g., an endovascular coil) during anendovascular procedure as shown in FIGS. 22A-22F. Some embodiments maybe configured to output a success notification (step 3112), for exampleif the severed state of the medical instrument 1220 is detected by step3108 (case 3110).

Consistent with disclosed embodiments, the success notification mayindicate that a distal section of the medical instrument may be releasedfrom the catheter while a proximal section of the medical instrument,having been severed from the distal section, may remain within the lumenof the catheter. As used herein, indicate may refer to demonstrating,expressing, illustrating, making apparent, signaling or another means ofsuggesting. As used herein, release may refer to freeing, letting go,liberating, breaking or allowing or enabling something to move or actfreely. As used herein, remain may refer to continuing, lingering,persisting or staying in a place that an object has been occupying. Forexample, the medical instrument (e.g., an endovascular coil) may besevered into two pieces where the distal section of the endovascularcoil may be released from the catheter and advance into a treatment site(e.g., an aneurysm) and the proximal section of the endovascular coilmay remain within the lumen of the catheter. Thus, the successnotification (e.g., a blinking LED) may turn on to indicate that thedistal section may be released from the catheter and the proximalsection may remain within the lumen of catheter. In another example, inwhich the endovascular coil is severed into two pieces, the distalsection may still be partially or wholly within the lumen of thecatheter along with the proximal section. Thus, the successnotification, a blinking LED, will not turn on to indicate that thedistal section is still within the lumen of the catheter.

FIG. 18A depicts a severed coil section 1826 and a remaining coilsection 1828 of a medical instrument 1220. FIG. 18B depicts anembodiment where the success notification outputted by step 3112 mayindicate that a severed distal section of the endovascular coil (i.e.,section 1826) has been released from a catheter 1210 while a proximalsection 1828 of the endovascular coil, having been severed from thedistal section 1826, remains within an inner lumen 1214 of the catheter1210.

Consistent with disclosed embodiments, after the success notification,embodiments may be further configured to obtain a second input toactivate the partitioning mechanism while the catheter may be positionedwithin the body, the second input associated with the proximal sectionof the medical instrument. As used herein, a second input may refer tothe next, subsequent, succeeding or other input coming after the firstinput. For example, the second input may be associated with the proximalend, or the end closer to the user or operator of the medicalinstrument. Consistent with disclosed embodiments, the operations mayfurther be configured to activate the partitioning mechanism in responseto the second input. Further, the operations may be configured whereinactivating the partitioning mechanism in response to the second inputmay include selecting an additional quantity of energy for delivery bythe partitioning mechanism, wherein the additional quantity is selectedbased on a structural property of the proximal section of the medicalinstrument and controlling the partitioning mechanism for delivery ofthe selected additional quantity of energy. Further, the operations maybe configured to obtain additional partitioning outcome data followingthe activation of the partitioning mechanism in response to the secondinput. Consistent with disclosed embodiments, the operations maydetermine, based on the additional partitioning outcome data, whetherthe proximal section of the medical instrument may be in a severed stateor a connected state. Further, the operations may output a secondsuccess notification if the severed state of the proximal section of themedical instrument may be detected. Consistent with disclosedembodiments, if the connected state of the proximal section of themedical instrument may be detected, the operations may output at leastone of (i) a second control signal to vary activation of thepartitioning mechanism or (ii) an instruction to reposition the proximalsection of the medical instrument relative to the partitioningmechanism.

FIG. 31 depicts instructions for monitoring partitioning 3100 of amedical instrument 1220 (e.g., an endovascular coil) during anendovascular procedure as shown in FIGS. 22A-22F. Some embodiments mayfurther be configured such that after outputting a success notificationby step 3112, a second input is obtained to activate the partitioningmechanism while a catheter 1210 (e.g., a microcatheter) is positionedwithin the body, the second input being associated with the proximalsection of the endovascular coil 1220. The operations may further beconfigured to activate the partitioning mechanism in response to thesecond input (step 3104). Further, the operations may be configured toobtain additional partitioning outcome data (step 3106) following theactivation of the partitioning mechanism in response to the second inputby step 3104. Additionally, the operations may determine, based on theadditional partitioning outcome data, whether the proximal section ofthe medical instrument 1220 (e.g., endovascular coil) is in a severedstate or a connected state (step 3108). Further, the operations mayoutput a second success notification (step 3112) if the severed state ofthe proximal section of the medical instrument 1220 is detected (case3110). Consistent with disclosed embodiments, if the connected state ofthe proximal section of medical instrument 1220 is detected (case 3114),the operations may output at least one of (i) a second control signal tovary activation of the partitioning mechanism (step 3116) or (ii) aninstruction to reposition the proximal section of medical instrument1220 relative to the partitioning mechanism (step 3118).

Consistent with disclosed embodiments, the operations may include, ifthe connected state of the medical instrument may be detected,outputting at least one of: (i) a control signal to vary activation ofthe partitioning mechanism, or (ii) an instruction to reposition themedical instrument relative to the partitioning mechanism. As usedherein a control signal may refer to a prompt, indicator, indication,communication, message, alert, movement, action or other action used toconvey information or instructions. As used herein, vary activation mayrefer to differing in amount, degree or nature of switching on, turningon, starting, triggering or any other means to make the partitioningmechanism operative. For example, if the connected state of the medicalinstrument (e.g., an endovascular coil) is detected, a blinking LED, asound, a display message, or haptic feedback may be made known to theuser of the medical device to either start the partitioning mechanismagain, stop the partitioning mechanism and/or repetitively start andstop the partitioning mechanism after advancing the medical device orretreating the medical device in relation to the treatment site (e.g.,an aneurysm). Some embodiments may be configured to output the controlsignal to vary the activation of the partitioning mechanism which mayinclude causing the partitioning mechanism to change a quantity ofenergy delivered by the at least one electrode to the adjacent portionof the medical instrument. For example, the control signal may output afaster blinking LED or a louder sound which may cause the partitioningmechanism to change the quantity of energy delivered to be larger thanthe quantity of energy delivered before the output by the at least oneelectrode to the adjacent portion of the medical instrument. In anotherexample, the control signal may output a slower blinking LED or a softersound which may cause the partitioning mechanism to change the quantityof energy delivered to be smaller than the quantity of energy deliveredbefore the output by the at least one electrode to the adjacent portionof the medical instrument.

FIG. 31 depicts instructions for monitoring partitioning 3100 of amedical instrument 1220 (e.g., an endovascular coil) during anendovascular procedure as shown in FIGS. 22A-22F. Some embodiments maybe configured to include, if the connected state of medical instrumentis detected (case 3114), outputting at least one of: (i) a controlsignal to vary activation of the partitioning mechanism (by step 3116),or (ii) an instruction to reposition the medical instrument 1220relative to the partitioning mechanism (by step 3118). Further, someembodiments may be configured to output the control signal to vary theactivation of the partitioning mechanism (step 3116) which may includecausing the partitioning mechanism to change a quantity of energydelivered (step 3120) by the at least one electrode 1242 to the adjacentportion of the medical instrument 1220.

Consistent with disclosed embodiments, if the connected state of themedical instrument may be detected, the operations may output aninstruction to reposition the medical instrument relative to thepartitioning mechanism. As used herein, an instruction may refer to anorder, command, directive, dictation, demand or other detailedinformation telling how something should be done. As used herein,reposition may refer to moving, shifting, relocating or placing in adifferent position before the next activation of the partitioningmechanism. For example, the operations may instruct the user to move themedical instrument (e.g., an endovascular coil) forward, backward, toone side, or to the other side relative to the partitioning mechanism.

FIG. 31 depicts instructions for monitoring partitioning 3100 of amedical instrument 1220 (e.g., an endovascular coil) during anendovascular procedure as shown in FIGS. 22A-22F. Some embodiments, ifthe connected state of the medical instrument 1220 is detected (case3114), the operations may output an instruction to reposition themedical instrument 1220 relative to the partitioning mechanism (step3118).

According to another embodiment of the present disclosure, a system formonitoring partitioning of a medical instrument during an endovascularprocedure may be provided. Consistent with disclosed embodiments, thesystem may be configured to comprise at least one processor. The atleast one processor may be configured to obtain an input to activate apartitioning mechanism associated with a medical instrument within alumen of a catheter, the catheter being positioned within a body. The atleast one processor may be configured to activate the partitioningmechanism in response to the input. The at least one processor mayobtain partitioning outcome data following the activation. The at leastone processor may determine, based on the partitioning outcome data,whether the medical instrument may be in a severed state or a connectedstate. The at least one processor, if the severed state of the medicalinstrument may be detected, output a success notification. The at leastone process, if the connected state of the medical instrument may bedetected, output at least one of (i) a control signal to vary activationof the partitioning mechanism or (ii) an instruction to reposition themedical instrument to the partitioning mechanism.

According to another embodiment of the present disclosure, a method forpartitioning of a medical instrument during an endovascular proceduremay be provided. The method may be configured to obtain an input toactivate a partitioning mechanism associated with a medical instrumentwithin a lumen of a catheter, the catheter being positioned within abody. The method may be configured to activate the partitioningmechanism in response to the input. The method may obtain partitioningoutcome data following the activation. The method may determine, basedon the partitioning outcome data, whether the medical instrument may bein a severed state or a connected state. The method, if the severedstate of the medical instrument may be detected, output a successnotification. The method, if the connected state of the medicalinstrument may be detected, output at least one of (i) a control signalto vary activation of the partitioning mechanism or (ii) an instructionto reposition the medical instrument to the partitioning mechanism.

In some embodiments, an endovascular device may be provided that isconfigured to deliver an endovascular coil to a treatment location, suchas an aneurysm or another hollow body structure. The endovascular devicemay include a coil partitioning mechanism, such as an electrode pair ora mechanical cutter, that may be configured to sever the coil at anylocation along its length. Advantageously, the coil partitioningmechanism may allow treatment of a hollow body structure using a single,continuous coil structure rather than multiple pieces of coil having apredetermined, standardized length which must be delivered one-by-one tothe treatment location. For example, a desired length of the single,continuous coil structure may be advanced from the endovascular deviceand severed using the coil partitioning mechanism, thus separating thedesired length of coil from the remainder of the single, continuous coilstructure and providing for delivery of the desired length of coil tothe hollow body structure.

Embodiments disclosed herein may provide a mechanism for tracking theamount of coil that has been advanced from the endovascular device andthe length of coil remaining in the endovascular device for future use.This coil tracking data may be used, for example, to determine when adesired length of coil has been advanced from the endovascular deviceand can be severed using the coil partitioning mechanism. Additionally,or alternatively, the coil tracking data may be provided to determinewhether a remaining length of coil in the endovascular device issufficient to treat the patient (e.g., to fill a hollow body structure),or whether the coil must be replaced with another, different coil.Replacement of the coil is time consuming, therefore prolonging theprocedure and increasing the risk of complications. Thus, minimizing thenumber of coil replacements is desired. Advantageously, theseembodiments may ensure that the hollow body structure is neitherover-nor under-packed, but that it has instead been packed with thecorrect amount of coil to achieve a desired therapeutic outcome, such asblocking blood flow into the hollow body structure.

Aspects of this disclosure may relate to systems, devices, methods, andnon-transitory computer readable media containing instructions toperform operations for monitoring and facilitating endovascular coildelivery. For ease of discussion, a method for monitoring andfacilitating endovascular coil delivery is described below, with theunderstanding that aspects of the method apply equally to systems,devices, and instructions contained by non-transitory computer readablemedia. For example, some aspects of such a method may occurelectronically over a network that is either wired, wireless, or both.Other aspects of such a method may occur using non-electronic means. Ina broadest sense, the method is not limited to particular physicaland/or electronic instrumentalities, but rather may be accomplishedusing many differing instrumentalities.

As used herein, operations for monitoring and facilitating endovascularcoil delivery may include methods, steps, and processes for obtaininginformation related to at least one of movement of an endovascular coilrelative to a delivery device (e.g., a coil delivery catheter) and/orrelative to the patient's body, release of the endovascular coil fromthe delivery device, placement of the endovascular coil within thetreatment location, and partitioning or severing of the endovascularcoil by a coil partitioning mechanism. Additionally, or alternatively,operations for monitoring and facilitating endovascular coil deliverymay include methods, steps, and processes for obtaining informationrelated to delivery of an endovascular coil and, based on the obtainedinformation, outputting feedback for the endovascular coil deliveryoperation. Non-limiting examples of outputting feedback may includeproviding at least one indication to a user related to the endovascularcoil delivery operation, outputting a control signal for an automatedcoil delivery process, and recording the obtained information related tothe endovascular coil delivery.

Consistent with disclosed embodiments, methods for monitoring andfacilitating endovascular coil delivery may include obtaining a firstinput from a coil movement sensor associated with an endovascular coilwithin a lumen of a catheter positioned within a body. As used herein, acoil movement sensor may include any device or mechanism configured tomeasure at least one variable related to movement of an endovascularcoil through an inner lumen of a catheter (e.g., a coil deliverycatheter) or another type of flexible medical tubing. The coil movementsensor may be configured to measure the at least one variable related tothe movement of the endovascular coil while the catheter and the coilare positioned within the body of a patient, such as during anendovascular procedure.

In some embodiments, a coil movement sensor may be configured to measuredisplacement of the endovascular coil relative to the catheter. Forexample, the coil movement sensor may be configured to measure an axiallength of the endovascular coil that passes in a distal direction past adesignated location of the catheter. Some non-limiting examples of thedesignated location of the catheter may include a distal tip of thecatheter, a proximal tip of the catheter, any location within or uponthe catheter, a location of a second device affixed to the catheter(such as the location of a coil partitioning mechanism or a location ofthe coil movement sensor), or any other suitable location of thecatheter relative to which movement of the endovascular coil may bemeasured. Additionally, or alternatively, a coil movement sensor may beconfigured to measure the speed, linear direction, and/or rotationaldirection of movement of the endovascular coil relative to the catheter.As used herein, “associated with” may mean that the coil movement sensoris configured to measure at least one variable related to movement ofthe endovascular coil relative to the catheter, as discussed above.

In some embodiments, the coil movement sensor may include anelectromagnetic sensor. For example, the endovascular coil may beconstructed at least partially from a metal or may otherwise beconfigured to have magnetic properties. In one example, movement of theendovascular coil relative to the designated location of the cathetermay cause electric current to flow through conductive material includedin the electromagnetic sensor. In this example, the coil movement sensormay be configured to measure the electric current flowing through theconductive material and/or characteristics thereof and may determine atleast one variable related to the movement of the endovascular coilbased on the measured electrical current and/or the characteristics ofthe electrical current. Some non-limiting examples of suchcharacteristics of electrical current may include net rate of flow,amplitude, frequency, and so forth. In another example, movement of theendovascular coil relative to the designated location of the cathetermay cause changes in an electrical resistance of an element. In thisexample, the coil movement sensor may be configured to measure theelectrical resistance of the element and may determine at least onevariable related to the movement of the endovascular coil based on themeasured electrical resistance. In yet another example, movement of theendovascular coil relative to the designated location of the cathetermay cause changes in an electrical capacitance of an element. In thisexample, the coil movement sensor may be configured to measure theelectrical capacitance of the element and may determine at least onevariable related to the movement of the endovascular coil based on themeasured electrical capacitance. In an additional example, movement ofthe endovascular coil relative to the designated location of thecatheter may cause changes in an electromagnetic field. In this example,the coil movement sensor may be configured to measure theelectromagnetic field in at least one place and may determine at leastone variable related to the movement of the endovascular coil based onthe measured electromagnetic field in the at least one place. In yetanother example, movement of the endovascular coil relative to thedesignated location of the catheter may cause changes in a difference ofelectrical potential between two places. In this example, the coilmovement sensor may be configured to measure the difference ofelectrical potential between the two places and may determine at leastone variable related to the movement of the endovascular coil based onthe measured difference of electrical potential between the two places.The at least one variable related to movement of the endovascular coilmay include a position of the endovascular coil, a speed and/or adirection of movement of the endovascular coil relative to the catheter,and a length of endovascular coil that passes through the designatedlocation of the catheter. A non-limiting example of an electromagneticsensor may include a linear variable displacement transducer.

In some embodiments, the coil movement sensor may include a mechanicalsensor. In some embodiments, the mechanical sensor may include astructure configured to be moved by the endovascular coil, eitherdirectly or indirectly, as the endovascular coil moves through thedesignated location of the catheter. Some non-limiting examples of thestructure of the mechanical sensor may include a roller configured to berotated by movement of the endovascular coil, or a structure configuredto be moved in a lateral direction away from the center of the lumen ofthe catheter during movement of the endovascular coil. The coil movementsensor may be configured to measure the motion of the structure of themechanical sensor and may determine at least one variable related to themovement of the endovascular coil based on the measured motion of thestructure. The at least one variable related to movement of theendovascular coil may include a position of the endovascular coil, aspeed and/or a direction of movement of the endovascular coil relativeto the catheter, and a length of endovascular coil that passes throughthe designated location of the catheter.

In some embodiments, the coil movement sensor may include an imagingdevice configured to obtain at least one image of the endovascular coilor of a feature connected to the endovascular coil (e.g., an imagingmarker) while the endovascular coil is advanced through the catheterwithin the body of a patient. Based on the at least one image, the coilmovement sensor may be configured to determine the position of theendovascular coil relative to the catheter, including the length of thecoil positioned distal to (i.e., advanced beyond) the designatedlocation of the catheter. For example, the imaging device may be locatedoutside the body of the patient and may be configured as a computedtomography (CT) device, a magnetic resonance imaging (MM) device, anX-ray imaging device, an ultrasonic imaging device, or a deviceconfigured to employ any other imaging modality to capture an image ofthe endovascular coil or of a feature connected to the endovascularcoil. Additionally, or alternatively, an imaging device may be providedon the catheter and may obtain images of the endovascular coil as thecoil is advanced through the catheter. In one example, the coil movementsensor may analyze the images to determine the location of theendovascular coil, for example using object detection algorithms. In oneexample, the coil movement sensor may analyze the images using objecttracking algorithms to determine the motion of the catheter or todetermine the length of the coil passing through a particular region(such as a particular region of the catheter, the tip of the catheter,the coil partitioning mechanism, and so forth).

Some other non-limiting examples of a coil movement sensor may include alinear inductive position sensor, a draw-wire sensor, a linearpotentiometer, a Hall effect sensor, an eddy current sensor, a lasertriangulation sensor, and a magnetostrictive linear position sensor.

Consistent with disclosed embodiments, obtaining the first input fromthe coil movement sensor may include obtaining data related to movementof the endovascular coil relative to the catheter within a certainlength of time. Some non-limiting examples of data of the first inputmay include linear displacement data and/or rotational displacement dataof the endovascular coil relative to the catheter, an axial length ofthe endovascular coil that passes in a specified direction (e.g., in adistal direction) beyond a designated location of the catheter, thespeed of the movement of the endovascular coil, the direction of themovement of the endovascular coil, a length of time over which themovement of the endovascular coil is measured by the coil movementsensor, the position of the coil movement sensor relative to thecatheter, and the position of the designated location of the catheter(i.e., a reference point on the catheter for evaluating movement of theendovascular coil relative to the catheter).

FIGS. 26A and 26B depict an endovascular device 2600 with a firstnon-limiting example of a coil movement sensor 2692. Endovascular device2600 may include a flexible, elongated sheath 2610, which may beconfigured as a catheter in various embodiments. The first coil movementsensor 2692 may be connected to sheath 2610 and may be configured tomeasure movement of endovascular instrument 2620 (e.g., an endovascularcoil) relative to endovascular device 2600 and sheath 2610. In theexample depicted in FIGS. 26A and 26B, first coil movement sensor 2692may be embedded in or otherwise affixed to the inner wall of the sheathwithin a distal region of the sheath (e.g., within one inch of distaltip 2612 of the sheath and/or within one inch of the distal end 2602 ofthe endovascular device). However, first coil movement sensor 2692 mayalternatively be situated at any location along the length of the sheath2610. In the example depicted in FIGS. 26A and 26B, first coil movementsensor 2692 may include an electromagnetic sensor having conductivematerial through which electric current flows when endovascularinstrument 2620 is moved relative to endovascular device 2600. In oneexample, first coil movement sensor 2692 may be configured to measurethe electric current flowing through the conductive material and/orcharacteristics thereof and may determine at least one variable relatedto the movement of endovascular instrument 1220 based on the measuredelectrical current and/or the measured characteristics of the electricalcurrent, as discussed above. Some non-limiting examples of suchcharacteristics of electrical current may include net rate of flow,amplitude, frequency, and so forth. In alternative examples,endovascular device 2600 may include a mechanical coil movement sensorconnected to sheath 2610, as also discussed above. Other possibleimplementations of first coil movement sensor 2692 are discussed herein.

FIGS. 26A and 26B additionally depict a second non-limiting example of acoil movement sensor 2694 including an imaging device positioned outsideof the patient's body. Second coil movement sensor 2694 may beconfigured to obtain images of endovascular instrument 2620 or of afeature connected to the instrument (e.g., an imaging marker) while theinstrument is moved through the inner lumen of the endovascular device2600 within the body of a patient. Based on the images of endovascularinstrument 2620 or the feature connected to the instrument, the secondcoil movement sensor 2694 may be configured to measure the movement ofinstrument 2620 relative to endovascular device 2600, as discussedabove.

FIGS. 10A-10C depict a system 1000 for delivering and cutting anendovascular coil 120, including another non-limiting example of a coilmovement sensor 1090. Coil movement sensor 1090 may be connected to theinner wall of microcatheter 1010 in a distal region of the microcatheter(e.g., coil movement sensor 1090 may be spaced a distance of one inch orless from the distal end of microcatheter 1010). Alternatively, coilmovement sensor may be placed at any other location along the length ofmicrocatheter 1010. Coil movement sensor 1090 may include anelectromagnetic sensor configured to measure movement of endovascularcoil 120 through the inner lumen of microcatheter 1010 and may beconfigured to determine a length of endovascular coil 120 located in adistal direction from a designated location of microcatheter 1010, suchas the distal end of microcatheter 1010, the location of sensor 1090,the location of electrode 1042, or the distal end of cylindrical base1050. Microcatheter 1010 may additionally, or alternatively, include adifferent configuration of coil movement sensor, as discussed above(e.g., a mechanical sensor and/or an imaging device).

Consistent with disclosed embodiments, the catheter may include a coilpartitioning mechanism configured to sever the endovascular coil. Insome embodiments, the coil partitioning mechanism may include at leastone electrode associated with the catheter and configured to deliverenergy to the endovascular coil in a quantity sufficient to sever theendovascular coil. As used herein, “associated with” may mean that theat least one electrode is affixed or connected to the catheter or thatthe at least one electrode is connected to a structure outside of thecatheter and may be brought into physical contact with an endovascularcoil within the lumen of the catheter. As discussed herein, the at leastone electrode may be configured to deliver energy to the endovascularcoil in a quantity sufficient to sever the endovascular coil intomultiple segments, so that a first segment of the coil (e.g., a distalsegment) may be delivered out of the endovascular device to a treatmentlocation while a second segment of the coil (e.g., a proximal segment)may remain within the endovascular device.

In some embodiments, the at least one electrode of the coil partitioningmechanism may be situated within an inner lumen of the catheter in adistal portion of the catheterIn some embodiments, the coil partitioningmechanism may include an electrode pair, with both electrodes affixed orconnected to the inner wall of the catheter lumen and configured to bebrought into physical contact with the endovascular coil to deliverelectrical current to the coil.

Consistent with disclosed embodiments, methods for monitoring andfacilitating endovascular coil delivery may include obtaining, after thefirst input, a second input to activate the coil partitioning mechanism.In some embodiments, the second input may be obtained when it isdetermined (e.g., by a user or a processor) that a desired length of theendovascular coil is arranged distal to the coil partitioning mechanism.Thus, when the coil partitioning mechanism is activated, the segment ofcoil that is severed from the rest of the endovascular coil has thedesired length and is therefore suitable for delivery to the treatmentlocation.

In some embodiments, a user such as a doctor may input a command toactivate the coil partitioning mechanism with a user input device, whichmay in turn convey a second input corresponding to the user command toat least one system processor. A non-limiting example of a user inputdevice may include user input device 1910 of FIG. 19, which may convey auser command to activate the coil partitioning mechanism to control unit1900. Additionally, or alternatively, the second input may include asignal received from a system processor as part of an automated processfor endovascular coil delivery. For example, a system processorexecuting an automated endovascular coil delivery process may determinewhen to activate the coil partitioning mechanism (e.g., based on sensordata indicative of the location of the endovascular coil) and may outputthe second input when it is determined that the coil partitioningmechanism should be activated. For example, control unit 1900 of FIG. 19may be configured to execute an automated process for delivering andsevering an endovascular coil with a delivery catheter. Control unit1900 may obtain data indicative of the location of the endovascular coil(e.g., from the coil movement sensor) and may output the second input toactivate the coil partitioning mechanism when it is determined that theendovascular coil is correctly placed to be severed by the coilpartitioning mechanism. In some embodiments, control unit 1900 mayoutput the second input to a processor of electrode control component1940, which may be configured to control activation of the coilpartitioning mechanism.

Consistent with disclosed embodiments, methods for monitoring andfacilitating endovascular coil delivery may include activating, inresponse to the second input, the coil partitioning mechanism to severthe endovascular coil into a first coil section for delivery from thecatheter and a residual second coil section. In some embodiments,activating the coil partitioning mechanism may include controlling atleast one electrode to deliver electrical current to the endovascularcoil in order to sever the coil. Optionally, activating the coilpartitioning mechanism may also include controlling the constrictor tonarrow the inner lumen of the catheter in order to bring theendovascular coil in physical contact with the electrode pair, thusclosing the electrical circuit. As a result, the electrode pair may beconfigured to deliver a sufficient amount of energy to the endovascularcoil to sever the coil.

In some embodiments, the first coil section may include the distal-mostportion of the endovascular coil prior to activation of the coilpartitioning mechanism. That is, the first coil section may be a portionof the endovascular coil that is severed from the remainder of the coiland may be released from the catheter for delivery to a treatmentlocation. In some embodiments, the residual second coil section may be aportion of the endovascular coil that is proximal to the first coilsection. That is, the second coil section may remain within the catheterand/or a coil storage mechanism after activation of the coilpartitioning mechanism, such that the second coil section is notreleased from the catheter along with the first coil section. The secondcoil section may become the distal-most portion of the endovascular coilafter the first coil section is severed.

In a non-limiting example, FIGS. 18A and 18B depict activation of a coilpartitioning mechanism to sever endovascular coil 1220 into a first coilsection 1826 and a residual second coil section 1828. In the embodimentshown in FIGS. 18A and 18B, activation of the coil partitioningmechanism may include causing constrictor 1260 to push endovascular coil1220 into contact with first electrode 1242 and sealing distal tip 1232(i.e., the second electrode), and activating electrode 1242 to delivercurrent to the adjacent coil section 1724 in order to sever the coil. Asa result, the first coil section 1826 may be severed from the rest ofthe endovascular coil (i.e., from second coil section 1828) and, asshown in FIG. 18B, may be released from the distal end of catheter 1210for delivery to a treatment location in the body of the patient. Secondcoil section 1828 may remain within catheter 1210, becoming thedistal-most remaining portion of the endovascular coil.

Consistent with disclosed embodiments, methods for monitoring andfacilitating endovascular coil delivery may include determining, basedon at least the first input and the second input, a length of the secondcoil section. In some embodiments, the length of the second coil sectionmay indicate how much of the endovascular coil remains within thecatheter for future use. For example, and as discussed above, the firstinput may include data indicating displacement of the endovascular coilrelative to the catheter. In some embodiments, coil displacement data ofthe first input may be used to determine the length of coil that isarranged distal to the coil partitioning mechanism. Then, when thesecond input is obtained, it may indicate that the coil partitioningmechanism has been activated and severed the coil. The length of thesecond coil section may then be determined as the difference between thelength of the endovascular coil prior to activation of the coilpartitioning mechanism and the length of coil removed by the activationof the coil partitioning mechanism (e.g., the length of coil arrangeddistal to the coil partitioning mechanism when activation occurred).

In some embodiments, the coil movement sensor may be positioned at adifferent location on the catheter than the coil partitioning mechanism.Thus, the coil displacement measured by the coil movement sensor may bedifferent from the true value of the length of coil arranged distal tothe coil partitioning mechanism. The difference between these values maybe equal to the linear distance between the sensor and the partitioningmechanism. Thus, this linear distance may be obtained in order tocorrect this difference and obtain an accurate measurement of the lengthof coil distal to the partitioning mechanism.

In some embodiments, disclosed methods may include obtaining a thirdinput corresponding to a passage of a distal tip of the endovascularcoil through the coil partitioning mechanism and determining the lengthof the second coil section based on at least the first input, the secondinput, and the third input. For example, the third input may designatethe beginning of the coil delivery operation, when the first piece ofcoil is being delivered through the catheter. In such cases, the thirdinput may signal the beginning of measuring movement of the endovascularcoil (that is, the time 0 for obtaining data from the coil movementsensor). In alternative embodiments, the third input may correspond topassage of the distal tip of the endovascular coil through anotherlocation on the catheter, such as the distal end of the catheter, theproximal end of the catheter, the location of the coil movement sensor,or any other location on the catheter.

In some embodiments, disclosed methods may include determining, based onat least the first input and the second input, a total length of aplurality of sections of the endovascular coil severed by the coilpartitioning mechanism for delivery from the catheter. For example, theendovascular coil may be severed into three or more pieces by multipleactivations of the coil partitioning mechanism. In such cases, thedisplacement data for each severed coil section may be obtained andadded to determine the total length of the severed coil sections. Thelength of the second coil section (i.e., the amount of coil remaining inthe catheter) may be determined as the difference between the originallength of the endovascular coil and the total length of the severed coilsections.

Consistent with disclosed embodiments, methods for monitoring andfacilitating endovascular coil delivery may include outputting a signalbased on the determined length of the second coil section. For example,outputting the signal may include providing at least one indication ofthe determined length of the second coil section to a user. For example,the at least one indication of the determined length may be providedvisually, textually, numerically, audibly, through a graphical userinterface, and so forth. In another example, outputting the signal mayinclude providing at least one indication of the determined length ofthe second coil section to at least one of an automated process, anexternal device or a memory unit. For example, the at least oneindication of the determined length of the second coil section may betransmitted to an external device using a digital communication device,may be stored in a memory unit, may be provided digitally, and so forth.In yet another example, outputting the signal may include adding atleast one indication of the determined length of the second coil sectionto a log, for example to an electronic log stored in a digital memoryunit. In some embodiments, disclosed methods may also include outputtinga second signal based on the determined total length of the plurality ofsevered sections of the endovascular coil (as discussed above).Advantageously, the second signal may indicate (e.g., to a user orprocessor) the total length of endovascular coil that has already beendelivered to the treatment location.

For example, outputting the signal based on the determined length of thesecond coil section may include displaying, on a graphical userinterface, at least one visual indication of the determined length ofthe second coil section. In some embodiments, outputting the signal mayinclude displaying, on the graphical user interface, at least oneadditional visual indication, such as an indication of the originallength of the endovascular coil, an indication of the length of thefirst coil section, an indication of the total amount of coil deliveredto the treatment location, an identifier of the endovascular coil,imaging data obtained from an imaging device, an indication or image ofthe delivery location, a patient identifier, or a timer.

As used herein, a graphical user interface (GUI) may include aninterface through which a user may interact with electronic devices suchas computers, laptops, surgical control devices and panels, displayscreens, televisions, hand-held devices, smartphones, tablets,touchscreen devices, and other appliances. The graphical user interfacemay be configured to output data (e.g., display at least one visualindication) and also to receive input data directly (e.g., viamanipulation of a touch screen with a finger) or indirectly (e.g., via auser input device such as a mouse, trackball, or stylus). The graphicaluser interface may use icons, menus and/or other visual indicator(graphics) representations to display information and related usercontrols.

In some embodiments, the graphical user interface may be associated withthe at least one processor or other device performing the disclosedoperations for monitoring and facilitating endovascular coil delivery.In a non-limiting example, control unit 1900 depicted in FIG. 19 mayinclude at least one processor 1902 configured to determine the lengthof the second coil section, as discussed herein, and to output a signalto graphical user interface 1920 to display at least one visualindication of the determined length of the second coil section.Additionally, or alternatively, the graphical user interface may beassociated with an external computing device, such as a surgical controldevice or panel, a mobile phone, a tablet, a laptop, a desktop computer,a computer terminal, a wearable device (including smart watches, smartglasses, smart jewelry, head-mounted displays, etc.), or any otherelectronic device capable of receiving a user input and displayinginformation.

In some embodiments, the at least one visual indication of thedetermined length of the second coil section may be displayed by thegraphical user interface such that the at least one visual indication isclearly visible on a screen of the graphical user interface as analphanumeric representation, a pictorial representation, and/or a userinstruction based at least in part on the determined length of thesecond coil section. Some non-limiting examples of a user instructionmay include an instruction to withdraw or remove the second coil sectionfrom the catheter, or a user instruction to replace the second coilsection with another endovascular coil.

Consistent with disclosed embodiments, outputting the signal based onthe determined length of the second coil section may additionally oralternatively include providing at least one audible indication of thedetermined length of the second coil section. In some embodiments,providing the at least one audible indication may include causing aspeaker or another audio output device to emit a sound, such as a verbal(i.e., spoken) indication of the determined length of the second coilsection, a ping, beep, ringtone, or any other audible alert. In someembodiments, providing the at least one audible indication mayadditionally include causing a speaker or another audio output device toemit at least one additional audible indication, such as an indicationof the original length of the endovascular coil, an indication of thelength of the first coil section, an indication of the total amount ofcoil delivered to the treatment location, an identifier of theendovascular coil, an indication of the delivery location of theendovascular coil, a patient identifier, or a timer.

In some embodiments, providing the at least one audible indication mayinclude causing a sound to be emitted by a speaker or another audiooutput device associated with the at least one processor or other deviceperforming the disclosed operations for monitoring and facilitatingendovascular coil delivery. In a non-limiting example, control unit 1900depicted in FIG. 19 may include at least one processor 1902 configuredto determine the length of the second coil section, as discussed herein,and to output a signal to audio output device 1922 to emit a soundindicating the determined length of the second coil section.

In some embodiments, providing the at least one audible indication mayinclude causing a speaker or another audio output device to emit analert notification sound or a user instruction based at least in part onthe determined length of the second coil section. Some non-limitingexamples of a user instruction may include an audible instruction towithdraw or remove the second coil section from the catheter, or anaudible instruction to replace the second coil section with anotherendovascular coil.

Consistent with disclosed embodiments, outputting the signal based onthe determined length of the second coil section may additionally oralternatively include recording information based on the determinedlength of the second coil section. In some embodiments, recording theinformation may include storing the information in a data structure; thedata structure may be a component of the disclosed system or a remotecomputing component (e.g., a cloud-based data structure). Recording theinformation may include storing the information contiguous ornon-contiguous memory. Moreover, the information may be recorded acrossmultiple data structures or servers, which may be owned or operated bythe same or different entities. Thus, the term “data structure” as usedherein in the singular is inclusive of plural data structures.

By way of a non-limiting example, as illustrated in FIG. 19,processor(s) 1902 may be configured to record the information based onthe determined length of the second coil section into data structure(s)1930. In some embodiments, the determined length of the second coilsection may be recorded in data structure(s) 1930; optionally,additional data may also be recorded in data structure(s) 1930 such asdata of the original length of the endovascular coil, data of the lengthof the first coil section, data of the total amount of coil delivered tothe treatment location, an identifier or other data of the endovascularcoil, imaging data obtained from an imaging device, data of the deliverylocation, a patient identifier, or timing data. Data structure(s) 1930may include a Random Access Memory (RAM), a Read-Only Memory (ROM), ahard disk, an optical disk, a magnetic medium, a flash memory, otherpermanent, fixed, or volatile memory, or any other mechanism capable ofstoring information or data.

Consistent with disclosed embodiments, outputting the signal based onthe determined length of the second coil section may additionally oralternatively include outputting a signal based on the determined lengthof the second coil section to control a coil advancement mechanism. Asused herein, a coil advancement mechanism may include a deviceconfigured to move the endovascular device axially and/or rotationallythrough the catheter. Some non-limiting examples of the coil advancementmechanism may include a driving roller, delivery wire, sheath, a slidingsupport structure, a torquer, or any other mechanism configured to movethe endovascular coil relative to the catheter. In some embodiments, thecoil advancement mechanism may be manually operated (e.g., by a doctoror other user). Additionally, or alternatively, the coil advancementmechanism may be semi-automated, or controlled by at least one processorbased on user commands received from a user input device such as abutton, keyboard, computer mouse, lever, joystick, foot switch or pedal,touch screen, or any other suitable user input device. Additionally, oralternatively, the coil advancement mechanism may be fully automatedsuch that at least one processor may control operations of the coiladvancement mechanism based on a pre-programmed coil delivery process,sensor data, imaging data, or any other suitable form of feedback orinput data.

In some embodiments, the coil advancement mechanism may be configured toautomatically control motion of the second coil section. As used herein,automatic control may refer to processes and operations performed by atleast one processor for controlling the coil advancement mechanism, asdiscussed above, independent of user commands for coil advancement. Insome embodiments, the at least one processor may use the determinedlength of the second coil section to automatically control movement ofthe second coil section. For example, the at least one processor may usethe determined length of the second coil section to determine if asufficient amount of coil remains in the catheter to complete theoperation; based on the determination, the at least one processor mayautomatically control the coil advancement mechanism to advance thesecond coil section distally in order to deliver the second coil sectionto the treatment location, or to move the second coil section proximallyin order to remove the second coil section from the catheter and, ifneeded, to replace the second coil section with a different endovascularcoil. Additionally, or alternatively, the at least one processor may usethe determined length of the second coil section to automaticallycontrol the coil advancement mechanism to move the second coil sectionto a desired location relative to the coil partitioning mechanism, sothat a desired length of the second coil section may be severed byactivation of the coil partitioning mechanism.

By way of a non-limiting example, as illustrated in FIG. 19,processor(s) 1902 may be configured to access instructions from memory1904 for performing operations of an automated process for deliveringthe endovascular coil 1220 to a treatment location, such as a hollowbody structure 2282. The instructions for the automated process mayindicate a treatment plan, including a type and amount of endovascularcoil to be delivered to the treatment location. Based on the treatmentplan, as well as feedback data from sensors 1912 and/or imaging device1914, processors 1902 may output control signals to coil advancingmechanism 1946 for advancing endovascular coil 1220 through a deliverydevice, such as endovascular device 1200.

Consistent with disclosed embodiments, methods for monitoring andfacilitating endovascular coil delivery may include comparing thedetermined length of the second coil section with a threshold andoutputting at least one output based on a result of the comparison. Insome embodiments, the threshold may indicate a desired length of theendovascular coil to be delivered to a treatment location, such as forfilling a hollow body structure. In some embodiments, the threshold maybe determined from images of the hollow body structure. For example,disclosed embodiments may include obtaining at least one medical imageof a hollow body structure associated with the endovascular coil andanalyzing the at least one medical image to determine the threshold. Asa non-limiting example, imaging device 1914 may be used to generate atleast one medical image of hollow body structure 2282, and the thresholdmay be determined based on analysis of the at least one medical image.In some embodiments, the threshold may be determined based on a currentpacking density of the hollow body structure determined by analyzing theat least one medical image. Additionally, or alternatively, thethreshold may be determined based on a size of the hollow body structuredetermined by analyzing the at least one medical image. In someembodiments, the threshold may be determined prior to the procedure fordelivering the endovascular coil. Additionally, or alternatively, thethreshold may be changed during the procedure based on, e.g., sensordata and/or imaging data of the hollow body structure. In someembodiments, the threshold may be based on a type of the endovascularcoil to be delivered to the hollow body structure. For example, aparameter of the endovascular coil (e.g., the coil's outer diameter) mayaffect the length of the coil that is required to treat the hollow bodystructure; the threshold may therefore be determined based on parametersof the endovascular coil(s) to be used for the procedure.

In some embodiments, methods for monitoring and facilitatingendovascular coil delivery may include outputting, based on a result ofthe comparison between the determined length of the second coil sectionand the threshold, at least one of a control signal to withdraw thesecond coil section from the catheter or an instruction to replace thesecond coil section with another endovascular coil. For example, the atleast one of the control signal or the instruction may be outputted whenthe result of the comparison indicates that the length of the secondcoil section is smaller than the threshold. In such cases, the secondcoil section is too short to treat the hollow body structure and shouldbe replaced with a longer coil. Additionally, or alternatively, the atleast one of the control signal or the instruction may be outputted whenit is determined that a different type of endovascular coil is requiredin the next stage of treatment. For example, the second coil section maybe configured as a filling coil (as discussed herein), but it may bedetermined (e.g., by at least one processor or a user) that the nexttype of coil to be delivered should be a finishing coil. In such cases,the at least one of the control signal or the instruction may beoutputted so that the second coil section (e.g., a filling coil) may bewithdrawn from the catheter and replaced with a suitable finishing coil.

In some embodiments, at least one processor may output the controlsignal to withdraw the second coil section to a coil advancementmechanism, as discussed herein, to cause the coil advancement mechanismto move the endovascular coil proximally until the coil is removed fromthe catheter. Optionally, a suitable replacement coil may be introducedinto the catheter and advanced distally by the coil advancementmechanism. In a non-limiting example, as illustrated in FIG. 19,processor(s) 1902 may be configured to output the control signal (asdiscussed above) to the coil advancing mechanism 1946, to cause the coiladvancing mechanism 1946 to withdraw endovascular coil 1220 from sheath1210 (e.g., a delivery catheter).

In some embodiments, at least one processor may output the instructionto replace the second coil section with another endovascular coil to auser via a graphical user interface, a speaker or other audio outputdevice, a haptic output device, or any other suitable notificationmechanism. In a non-limiting example, as illustrated in FIG. 19,processor(s) 1902 may be configured to control graphical user interface1920 and audio output device 1922 to output the instruction to the user.The instruction may include an indication that the second coil sectionis too short and/or a suggestion to replace the second coil section withanother endovascular coil.

Consistent with disclosed embodiments, methods for monitoring andfacilitating endovascular coil delivery may include obtaining a thirdinput indicative of a prior activation of the coil partitioningmechanism and determining a length of the first coil section based on atleast the first input, the second input, and the third input. Forexample, at the time of the prior activation of the coil partitioningmechanism, the distal tip of the first coil section may have beenlocated at the coil partitioning mechanism (thus, the prior activationmay make the first coil section the distal-most portion of theendovascular coil). Thus, coil displacement detected between the prioractivation and the subsequent activation of the coil partitioningmechanism may be equal to the length of the first coil section (which issevered from the remainder of the endovascular coil, including thesecond coil section, by the subsequent activation of the coilpartitioning mechanism). In some embodiments, disclosed methods mayinclude outputting a second signal based on the determined length of thefirst coil section. Outputting the second signal may include any of theaforementioned embodiments of outputting the first signal.

Consistent with disclosed embodiments, the coil movement sensor may beconfigured to measure a net distance of movement of the endovascularcoil relative to the catheter. As used herein, the net distance ofmovement may include a difference between a total distance traveled bythe endovascular coil in a distal direction and a total distancetraveled by the endovascular coil in a proximal direction. That is, thecoil movement sensor may be configured to differentiate between distalmovement of the coil and proximal movement of the coil in order toaccurately detect the final axial location of the coil relative to thecatheter. For example, in embodiments in which the coil movement sensorincludes an electromagnetic sensor, the electromagnetic sensor may beconfigured such that movement of the coil in a first direction (e.g.,the distal direction) may induce an electric current having firstcharacteristics, while movement of the coil in a second, oppositedirection (e.g., the proximal direction) may induce an electric currenthaving second characteristics. Some non-limiting examples of suchcharacteristics may include at least one of amplitude of the electriccurrent being in a particular range of amplitudes, frequency of theelectric current being in a particular range of frequencies, net rate offlow of the electric current being in a particular range of rates, andso forth. In this example, the direction of movement of the endovascularcoil may be determined based on whether the measured electric currenthave the first characteristics or the second characteristics. In anotherexample, in embodiments in which the coil movement sensor includes anelectromagnetic sensor, the electromagnetic sensor may be configuredsuch that movement of the coil in a first direction (e.g., the distaldirection) may cause an electrical resistance of an element to be in afirst range of values, while movement of the coil in a second, oppositedirection (e.g., the proximal direction) may cause the electricalresistance of the element to be in a second range of values. In thisexample, the direction of movement of the endovascular coil may bedetermined based on whether the measured electrical resistance of theelement is in the first range of values of in the second range ofvalues.

In yet another example, in embodiments in which the coil movement sensorincludes an electromagnetic sensor, the electromagnetic sensor may beconfigured such that movement of the coil in a first direction (e.g.,the distal direction) may cause an electrical capacitance of an elementto be in a first range of values, while movement of the coil in asecond, opposite direction (e.g., the proximal direction) may cause theelectrical capacitance of the element to be in a second range of values.In this example, the direction of movement of the endovascular coil maybe determined based on whether the measured electrical capacitance ofthe element is in the first range of values of in the second range ofvalues. In an additional example, in embodiments in which the coilmovement sensor includes an electromagnetic sensor, the electromagneticsensor may be configured such that movement of the coil in a firstdirection (e.g., the distal direction) may cause an electromagneticfield in at least one place to be in a first range of values, whilemovement of the coil in a second, opposite direction (e.g., the proximaldirection) may cause the electromagnetic field in the at least one placeto be in a second range of values. In this example, the direction ofmovement of the endovascular coil may be determined based on whether themeasured electromagnetic field in the at least one place is in the firstrange of values of in the second range of values. In another example, inembodiments in which the coil movement sensor includes anelectromagnetic sensor, the electromagnetic sensor may be configuredsuch that movement of the coil in a first direction (e.g., the distaldirection) may cause a difference of electrical potential between twoplaces to be in a first range of values, while movement of the coil in asecond, opposite direction (e.g., the proximal direction) may cause thedifference of electrical potential between the two places to be in asecond range of values. In this example, the direction of movement ofthe endovascular coil may be determined based on whether the measureddifference of electrical potential between the two places is in thefirst range of values of in the second range of values. Additionally, oralternatively, in embodiments in which the coil movement sensor includesa mechanical sensor, the movable structure of the mechanical sensor(discussed above) may be configured to move in a first direction whenthe endovascular coil moves distally and to move in another directionwhen the coil moves proximally. The coil movement sensor may thereforebe configured to determine the direction of movement of the endovascularcoil based on the movement of the movable structure of the mechanicalsensor.

In some embodiments, the endovascular coil may include at least onemarking readable by the coil movement sensor. In some embodiments, theendovascular coil may include multiple markings that are readable by thecoil movement sensor. For example, the endovascular coil may include amarking between different regions of the coil having differentstructural properties (e.g., at a location between a first region of theendovascular coil configured as a framing coil and a second region ofthe endovascular coil configured as a filling coil). Additionally, oralternatively, the endovascular coil may include a marking at a locationbetween the coil and another device or instrument (e.g., at a locationbetween the coil and a delivery wire). Additionally, or alternatively,the endovascular coil may include a marking at any suitable locationalong its length, including the distal tip and/or proximal tip of thecoil.

In some embodiments, the coil movement sensor may be configured todetermine the net distance of movement of the endovascular coil based onreadings of the at least one marking. For example, the coil movementsensor may include an imaging device configured to detect the at leastone marking of the endovascular coil while the coil and catheter arelocated within the body of a patient. The imaging device of the coilmovement sensor may detect the direction(s) and distance of movement ofthe at least one marking relative to the patient's body and/or relativeto the catheter, in order to determine the net distance of movement ofthe endovascular coil.

In a non-limiting example, FIGS. 26A and 26B depict an endovascular coil2620 including at least one marking 2621. In the example shown, the atleast one marking 2621 may include a winding of the coil constructedfrom a detectable material (e.g., a radiopaque material, or any othersuitable material configured to be detected by an imaging device).However, endovascular coil 2620 may additionally or alternativelyinclude another embodiment of the at least one marking, as discussedabove. In some embodiments, one or both of coil movement sensors 2692and 2694 may be configured to detect the direction and distance ofmovement of the at least one marking 2621 relative to the sheath 2610(e.g., a catheter) and/or relative to any other suitable point ofreference. The net distance of movement of endovascular coil 2620 may bedetermined (e.g., by a coil movement sensor, by at least one processor,etc.) based on the detected direction and distance of movement of themarking 2621.

Consistent with disclosed embodiments, the coil movement sensor may belocated at any suitable location along the catheter. The coil movementsensor may be located within the inner lumen of the catheter, on theouter surface of the catheter, or embedded within the side wall of thecatheter. In some embodiments, the coil movement sensor may be locatedwithin one inch of the coil partitioning mechanism. For example, thecoil movement sensor may be incorporated within the coil partitioningmechanism. Alternatively, the coil movement sensor may be located inclose proximity to the coil partitioning mechanism; for example, thecoil movement sensor may be located immediately adjacent to the coilpartitioning mechanism. In alternative embodiments, the coil movementsensor may be located within one inch of a distal tip of the catheter.In a non-limiting example, coil movement sensor 2692 depicted in FIGS.26A and 26B may be located within one inch of the distal tip 2612 ofsheath 2610 (which may be configured as a catheter). Additionally, oralternatively, coil movement sensor 2692 may be located within one inchof the distal end 2602 of endovascular device 2600.

Consistent with disclosed embodiments, the coil movement sensor may belocated outside the body and may be configured to capture images of, orotherwise detect, the endovascular coil or a device attached to the coilwhile the coil is located within the body of a patient. For example, andas discussed above, the coil movement sensor may include an imagingdevice located outside the body. According to such embodiments,obtaining the first input from the coil movement sensor may includereceiving a plurality of images of the endovascular coil captured by thecoil movement sensor, specifically by the imaging device. For example,the imaging device may be configured to determine a location of theendovascular coil and/or a marking on the endovascular coil in each ofthe images. For example, the images may be analyzed using objectdetection algorithms to determine the location of the endovascular coiland/or of the marking on the endovascular coil. In another example, theimages may be analyzed using tracking algorithms to determine changes tothe location of the endovascular coil and/or of the marking. The firstinput may be determined (e.g., by the coil movement sensor, by theimaging device, by at least one processor, etc.) based on a directionand speed of movement of the endovascular coil or marking between theplurality of images, based on the location of the coil, based on thelocation of the marking, and so forth.

In some embodiments, obtaining the first input from the coil movementsensor may include receiving a plurality of images captured by the coilmovement sensor of at least a portion of a device while the portion ofthe device is located outside the body of the patient. The device mayinclude a structure connected to the endovascular coil and having aportion (e.g., a proximal portion of the device) configured to bepositioned outside the body while the endovascular coil and the oppositeend of the device are positioned within the body. In some embodiments,the device may be configured to move the endovascular coil through thelumen of the catheter. Some non-limiting examples of the device mayinclude a shaft and a wire. In some embodiments, the plurality of imagesmay be analyzed to determine a movement of the device and/or a movementof a marking on the device, for example using tracking algorithms. Thefirst input may be obtained based on the determined movement of thedevice and/or the marking on the device.

FIG. 27 is a flowchart illustrating an example of a method 2700 formonitoring and facilitating endovascular coil delivery, consistent withdisclosed embodiments. Method 2700 may be performed by at least oneprocessor, such as one or more microprocessors. Additionally, oralternatively, a non-transitory computer readable medium may be providedcontaining instructions that when executed by at least one processor,cause the at least one processor to perform some or all of the steps ofmethod 2700. In some embodiments, method 2700 is not necessarily limitedto the steps illustrated, and any of the various embodiments describedherein may also be included in method 2700.

At step 2702, the method 2700 may include obtaining a first input from acoil movement sensor. As discussed herein, the coil movement sensor maybe associated with an endovascular coil within a lumen of a catheterpositioned within a body of a patient. The catheter may include a coilpartitioning mechanism configured to sever the endovascular coil. Insome embodiments, the catheter may additionally include a constrictorconfigured to narrow the inner lumen of the catheter in order to bringthe endovascular coil into contact with the coil partitioning mechanism.At step 2704, the method 2700 may include obtaining, after the firstinput, a second input to activate the coil partitioning mechanism. Asdiscussed herein, the second input may be received from a user (e.g.,via a user input device) and/or from a processor performing an automatedprocess for delivering an endovascular coil. At step 2706, the method2700 may include activating the coil partitioning mechanism in responseto the second input. In some embodiments, activation of the coilpartitioning mechanism may sever the endovascular coil into a first coilsection for delivery from the catheter and a residual second coilsection. At step 2708, the method 2700 may include determining a lengthof the second coil section severed by the coil partitioning mechanism atstep 2706. In some embodiments, the length of the second coil sectionmay be determined based on at least the first input and the secondinput. At step 2710, the method 2700 may include outputting a signalbased on the determined length of the second coil section. As describedherein, outputting the signal based on the determined length may includeat least one of outputting a user indication, recording informationbased on the determined length in a data structure, or outputting asignal for controlling a coil advancement mechanism configured to movethe endovascular coil relative to the catheter.

Systems and methods disclosed herein involve unconventional improvementsover conventional approaches. Descriptions of the disclosed embodimentsare not exhaustive and are not limited to the precise forms orembodiments disclosed. Modifications and adaptations of the embodimentswill be apparent from consideration of the specification and practice ofthe disclosed embodiments. Additionally, the disclosed embodiments arenot limited to the examples discussed herein.

The foregoing description has been presented for purposes ofillustration. It is not exhaustive and is not limited to the preciseforms or embodiments disclosed. Modifications and adaptations of theembodiments will be apparent from consideration of the specification andpractice of the disclosed embodiments. For example, the describedimplementations include hardware and software, but systems and methodsconsistent with the present disclosure may be implemented as hardwarealone.

The features and advantages of the disclosure are apparent from thedetailed specification, and thus, it is intended that the appendedclaims cover all systems and methods falling within the true spirit andscope of the disclosure. As used herein, the indefinite articles “a” and“an” mean “one or more.” Similarly, the use of a plural term does notnecessarily denote a plurality unless it is unambiguous in the givencontext. Words such as “and” or “or” mean “and/or” unless specificallydirected otherwise. Further, since numerous modifications and variationswill readily occur from studying the present disclosure, it is notdesired to limit the disclosure to the exact construction and operationillustrated and described, and, accordingly, all suitable modificationsand equivalents may be resorted to, falling within the scope of thedisclosure.

Computer programs based on the written description and methods of thisspecification are within the skill of a software developer. The variousfunctions, scripts, programs, or modules may be created using a varietyof programming techniques. For example, programs, scripts, functions,program sections or program modules may be designed in or by means oflanguages, including JAVASCRIPT, C, C++, JAVA, PHP, PYTHON, RUBY, PERL,BASH, or other programming or scripting languages. One or more of suchsoftware sections or modules may be integrated into a computer system,non-transitory computer readable media, or existing communicationssoftware. The programs, modules, or code may also be implemented orreplicated as firmware or circuit logic.

Moreover, while illustrative embodiments have been described herein, thescope may include any and all embodiments having equivalent elements,modifications, omissions, combinations (e.g., of aspects across variousembodiments), adaptations or alterations based on the presentdisclosure. The elements in the claims are to be interpreted broadlybased on the language employed in the claims and not limited to examplesdescribed in the present specification or during the prosecution of theapplication, which examples are to be construed as non-exclusive.Further, the steps of the disclosed methods may be modified in anymanner, including by reordering steps or inserting or deleting steps. Itis intended, therefore, that the specification and examples beconsidered as exemplary only, with a true scope and spirit beingindicated by the following claims and their full scope of equivalents.

1.-43. (canceled)
 44. An endovascular device, comprising: an elongatedflexible sheath defining a lumen with an inner opening sized forenabling selective advancement of an endovascular instrumenttherethrough, the sheath having at least a first region and a secondregion; an electrode within the first region of the sheath; and aconstrictor associated with the first region of the sheath, theconstrictor being configured, while at least the first region and thesecond region of the sheath are positioned within a body and in responseto an input received from outside the body, to reversibly narrow thelumen of the sheath in an area adjacent the electrode to thereby bringthe electrode into contact with an adjacent portion of the endovascularinstrument.
 45. The endovascular device of claim 44, constructed suchthat during constriction of the first region of the sheath, the secondregion of the sheath is configured to remain unconstricted.
 46. Theendovascular device of claim 44, wherein the endovascular instrument isan endovascular coil configured for bending within a hollow bodystructure upon discharge from the sheath, and wherein the electrode islocated in a distal region of the sheath and is configured to sever theendovascular coil following discharge of at least a portion of the coilfrom the sheath.
 47. The endovascular device of claim 44, wherein theelectrode is configured to make physical contact with the endovascularinstrument during constriction to enable the electrode to deliver energyto the endovascular instrument. 48.-49. (canceled)
 50. The endovasculardevice of claim 47, wherein the electrode is configured to deliverelectrical energy to the endovascular instrument and wherein theconstrictor is configured to press the electrode and the endovascularinstrument together in a manner reducing electrical impedance duringenergy delivery.
 51. The endovascular device of claim 44, wherein theconstrictor is configured such that constriction of the first region ofthe sheath closes an electrical circuit including the electrode and theendovascular instrument.
 52. The endovascular device of claim 44,wherein during constriction, the constrictor is configured to obstructaxial advancement of the endovascular instrument within the first regionof the sheath.
 53. The endovascular device of claim 44, wherein a firstsection of the lumen within the first region of the sheath has acircular cross-section during non-constriction, and wherein theconstrictor is configured to cause the cross-section of the firstsection of the lumen in an area of the constrictor to becomenon-circular.
 54. The endovascular device of claim 53, wherein a secondsection of the lumen within the second region of the sheath has acircular cross-section during constriction.
 55. The endovascular deviceof claim 44, wherein the constrictor is configured to selectively narrowthe lumen in response to a control signal received from a control devicepositioned outside the body.
 56. The endovascular device of claim 44,wherein the constrictor is configured to selectively narrow the lumen inresponse to at least one of: a change in temperature of at least aportion of the constrictor, delivery of electric current to theconstrictor, an application of electromagnetic force on the constrictor,or an application of mechanical force on the constrictor.
 57. Theendovascular device of claim 44, wherein at least a first portion of theconstrictor is located within the lumen of the sheath duringconstriction, and wherein at least a second portion of the constrictoris located outside the lumen of the sheath, adjacent an external surfaceof the sheath.
 58. The endovascular device of claim 44, wherein theconstrictor includes at least one obstructer configured to: liesubstantially flush with an outer surface of the first region of thesheath when the first region is non-constricted, and protrude into thelumen of the sheath when the first region is constricted.
 59. Theendovascular device of claim 58, wherein the at least one obstructerincludes a selectively inflatable balloon configured for expansion intothe lumen of the sheath when inflated.
 60. The endovascular device ofclaim 58, wherein the at least one obstructer includes at least twoobstructers spaced about a circumference of the lumen of the sheath. 61.The endovascular device of claim 58, wherein the at least one obstructerincludes at least one of: a plurality of obstructers locatedsubstantially at a same distance from a distal tip of the endovasculardevice, or a plurality of obstructers, each located at differingdistances from the distal tip of the endovascular device.
 62. Theendovascular device of claim 44, wherein the constrictor is configuredto cause exertion of a stronger friction force on the endovascularinstrument when constricted than when unconstricted.
 63. Theendovascular device of claim 44, wherein the constrictor is configuredto: constrict the first region of the sheath, and automaticallyunconstrict the first region of the sheath after a specified period oftime.
 64. The endovascular device of claim 44, wherein after narrowingthe lumen of the sheath in response to the input received from outsidethe body, the constrictor is configured to widen the lumen in responseto a second input received from outside the body.
 65. An endovasculartreatment method, comprising: delivering an endovascular instrument tohuman vasculature via a sheath having an electrode therein; while aportion of the sheath having the electrode is within a body, reversiblyconstricting the portion of the sheath having the electrode to narrow alumen within the sheath and thereby cause the electrode and theendovascular instrument to make physical contact; and while the portionof the sheath having the electrode is constricted, supplying electricalenergy to the electrode, to thereby deliver electrical energy to theendovascular instrument via the electrode. 66.-67. (canceled)
 68. Anon-transitory computer readable medium containing instructions thatwhen executed by at least one processor, cause the at least oneprocessor to perform operations for endovascular treatment, theoperations comprising: obtaining an input corresponding to delivery ofan endovascular instrument to human vasculature via a sheath having anelectrode therein; based on the input, and while a portion of the sheathhaving the electrode is within a body, causing reversible constrictionof the portion of the sheath having the electrode to narrow a lumenwithin the sheath and thereby cause the electrode and the endovascularinstrument to make physical contact; and while the portion of the sheathhaving the electrode is constricted, controlling supply of electricalenergy to the electrode, to thereby deliver electrical energy to theendovascular instrument via the electrode. 69.-138. (canceled)